Knowledge center

Explore our knowledge center, your go-to resource for insights and expertise in the field of life sciences. Here, you'll find a wealth of information, from in-depth whitepapers and blog articles to case studies, webinars, and regulatory updates.

Whether you're in pharma, biotech, medical devices, or any other industry, our diverse services and expert guidance are designed to keep you informed and ahead of industry trends. Dive into our content and stay connected with the latest advancements and best practices.

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Whitepaper

21 CFR Part 11 compliance checklist

Want to assess whether a computer system generates electronic records and uses electronic signatures, and whether the system complies with Part 11 of 21 CFR? Download this free checklist.

Whitepaper

Achieving laboratory compliance

This whitepaper explores the multifaceted aspects of laboratory compliance, including data integrity, quality control measures, and regulatory adherence.

Whitepaper

A Complete Guide to Computer System Validation

This guide aims to bring context and define the necessary and appropriate strategies for the validation of computerized systems. Download now.

Whitepaper

Analytical Method Validation

In this whitepaper, we will give an overview of the criteria to consider when validating your analytical method.

Whitepaper

Annual Product Quality Review in Pharma

Want to learn more about the importance, benefits, and key challenges related to the Annual Product Quality Review in Pharma? Then read on quickly!

Whitepaper

ISO 13485:2016 - Compliance Checklist

Are you up to date with the latest medical device QMS requirements? Download our free ISO 13485:2016 checklist to ensure compliance.

Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!

Whitepaper

Clinical evidence for In Vitro Diagnostics under IVDR

In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.

Whitepaper

Clinical investigations under MDR: key insights and practical experiences

This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.

Whitepaper

Digital Health - Exploring the landscape and future opportunities

This whitepaper informs you about digital health, key technology pillars, and new opportunities to anticipate future trends in your healthcare sector.

Whitepaper

Ensuring compliance and quality in Pharmacovigilance

The whitepaper emphasizes the importance of a robust pharmacovigilance QMS and a well-maintained Pharmacovigilance System Master File (PSMF). Download now.

Whitepaper

EUDRALEX Volume 4 Annex 11 Compliance Checklist

Assess your computer system's compliance with EudraLex Volume 4 Annex 11 guidelines using our checklist. Download now for GMP assurance.

Whitepaper

From V-model to Agile: how to embrace automation as part of the computerized system validation approach

This white paper explores why IT is shifting to agile, focuses on the prevalent Scrum methodology, and concludes with guidance on adapting system validation processes.

Whitepaper

GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations

Learn how to comply with GMP, GCP, and GLP regulations using the GAMP 5 Software Validation Approach. Download the whitepaper for more insights.

Whitepaper

GAMP categories for computerized systems: what are they and what are they for?

In this whitepaper, you will learn what GAMP is, what GAMP categories are for, and where to start if you are facing computerized systems validation.

Whitepaper

ICH Stability Studies on Pharmaceuticals

This whitepaper discusses the importance of different methods for testing the stability of pharmaceutical products, stability study guidelines, and other aspects related to the stability of...

Whitepaper

Innovations in ATMP: state of the industry in 2024

This whitepaper explores the innovations in ATMP and solutions in detail, with a focus on the current landscape as of April 2024. Download now.

Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.

Whitepaper

Mobile health on the rise: exploring the regulatory landscape for reimbursement

This whitepaper will help you navigate the maze of the DTx regulatory environment, highlighting several important countries and regulations.

Whitepaper

New GMP Facility Qualification: set-up, process and best practices

This whitepaper delves into the challenges of establishing a new GMP facility, focusing on potential pitfalls and best practices. Download now.

Whitepaper

Organic and mutagenic impurities in pharma

Ensure pharmaceutical quality and safety by controlling organic and mutagenic impurities. Download this whitepaper to learn more.

Whitepaper

The pathway from idea to patient under MDR

This guide explains the pathway and steps needed to test your device in human subjects, aiming to get your product to market. Download now.

Whitepaper

Regulatory Affairs for Pharma and Biotech

In this flyer, you will learn more about the regulatory services QbD Group provides for the pharmaceutical and biotechnology industries.

Whitepaper

Standards and regulations for software used in Medical Devices

Explore the essential standards and regulations for software used in Medical Devices, including IEC 62304 and IEC 82304. Download now.

Whitepaper

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

This whitepaper will walk you through the steps of conducting solid systematic SOTA literature searches for your clinical evaluation. Download now.

Whitepaper

The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization

Discover the key role of Regulatory Affairs in pharma and how Regulatory Affairs teams support product lifecycle management in this whitepaper. Download now.

Whitepaper

The One-Vigilance strategic roadmap to corporate excellence

This whitepaper introduces the concept of One Vigilance within the context of the current drug safety landscape. Download now.

Whitepaper

EU GMP: How to import your products into the EU?

Are you a medicinal product manufacturer looking to import your products into the EU in line with the latest EU-GMP import regulations? Download our guide.

Case study

Ensuring a smooth MDR transition for Oystershell's medical devices

The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our...

Case study

Ensuring pharmaceutical production quality: cleaning validation for government agency

Discover how QbD Group helped a client tackle dual validation challenges for their production lines, ensuring GMP compliance and AEMPS approval.

Case study

Ensuring timely launch: QbD Group's role in establishing a hemophilia drug production line

QbD Group has facilitated the launch of a new drug production line for treating hemophilia, overseeing the qualification of over 100 pieces of small-scale supporting equipment.

Case study

Guiding KU Leuven's glioblastoma research to the clinic with precision business planning

Helping KU Leuven advance glioblastoma research to the clinic with strategic business planning, funding support, and a roadmap for clinical impact.

Case study

Help BioLizard build their Quality Management System

QbD Group helped BioLizard document the fundamental processes of their QMS and enabled them to continue building it on their own.

Case study

Helping Abraca BioSystems to obtain ISO 13485 certification

QbD Group helped Abraca Biosystem gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.

Case study

Helping Relu to comply with changing regulations

QbD Group supported software company Relu with their expertise to comply with changing regulations.

Case study

Optimizing pharmacovigilance for a biotechnology leader

Discover how QbD Group improved pharmacovigilance for a global leader in biotechnology, ensuring regulatory compliance and patient safety.

Case study

Patient Support Program (PSP)

Learn about our patient support program (PSP) and how it helps manage customer support for a PV Spanish client. Resolve quality issues and ensure stability with QbD Pharma.

Case study

Quickly bringing a new COVID-19 medical device to market

Obtaining the required government certifications for a medical device is always a challenge. Especially when the COVID clock is ticking.

Case study

Revolutionizing pharmacovigilance: a success story of strategic partnership and seamless integration

Discover how QbD Group's expert support enhanced a pharmaceutical company's pharmacovigilance, leading to a favorable inspection outcome by the local Regulatory Authority (AEMPS).

Case study

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.

Case study

Supporting Oncomfort in developing and certifying their ISO 13485 QMS

QbD Group helped Oncomfort quickly implement and certify an ISO 13485 compliant Quality Management System.

Case study

The journey toward IVDR compliance for the LVOne device

QbD Group helped Upfront Diagnostics gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.

Webinar

3D Printing in the Healthcare World

Explore the challenges and opportunities of 3D printing in healthcare, featuring expert insights on regulations, pitfalls, and efficiency.

Webinar

Setting up ATMP Quality Management Systems: Strategies for Compliance and Success

Discover strategies for establishing a compliant and successful ATMP Quality Management System. Watch our webinar on demand.

Webinar

ATMP Supply Chain: Navigating the Challenges and Exploring the Vein-to-Vein Strategy

Explore the transformative ATMP journey and vein-to-vein strategy in our webinar. Learn how to navigate challenges and unlock the full potential of ATMPs.

Webinar

Drug-Device Combination Products and Article 117

Explore the regulatory complexities of Drug-Device Combination Products. Learn about Article 117 requirements, Notified Body Opinions, and more.

Webinar

How to manage mandatory communication of Toxicological Risks?

Learn how to effectively manage toxicological risks in the pharmaceutical industry by addressing, reporting, and mitigating potential harm.

Webinar

IVDR Extension Explained: Tips & Strategies

Gain valuable insights on the IVDR extension and its impact on IVD manufacturers with our webinar on demand.

Webinar

Mastering Clinical Performance Studies under IVDR

In the evolving regulatory landscape of IVDs, demonstrating clinical performance is more crucial and challenging than ever. Discover more in this webinar on demand.

Webinar

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Discover how to integrate clinical needs into medical device software design to meet MDR requirements. Watch our webinar on demand.

Webinar

From Requirements to Code: a unified MDSW development cycle that covers all requirements

Watch our webinar on demand to master medical device software development. Learn about IEC standards, cybersecurity, AI integration, and FDA expectations.

Webinar

From Concept to Market: Comprehensive Market Access Strategies for Medical Device Software

Learn how to launch your Medical Device Software successfully with expert insights on market access and commercialization strategies. Watch our webinar on demand.

Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.

Webinar

Technical Documentation Essentials for Medical Device Software

Gain practical insights on crafting MDR-compliant technical documentation for Medical Device Software.

Webinar

Post-Market Surveillance Requirements for Medical Devices and IVDs

Learn about post-market surveillance requirements under MDR and IVDR regulations. Gain insights from industry experts in this on-demand webinar.

Webinar

The Basic Concepts of the QbD Methodology

Learn the basics of QbD methodology with industry experts in this on-demand webinar.

Webinar

Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems

This webinar on demand will tell you more about the second edition of GAMP 5.

Webinar

Unlocking Strategic Value in Drug Safety for Life Sciences Organizations

Explore how drug safety teams can transform into proactive benefit drivers with the right tools & resources in this webinar on demand.

Webinar

Verification & Validation of Artificial Intelligence/ Machine Learning Medical Devices

Explore the impact of Artificial Intelligence and Machine Learning on medical device validation and verification processes.

Webinar

The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body

Learn about the Medical Device CE Certification Pathway, from classification to conformity assessment by a Notified Body. Join our webinar on demand.

Blog

Operational software compliance that adds value: essential pharma Q&A

In pharmaceutical operations, effective software compliance is vital for regulatory adherence, data security, and the integrity of patient-critical...

Blog

Operational software compliance in pharma: a practical guide

In the pharmaceutical industry, maintaining software compliance is a continuous process that extends beyond initial validation. The computerized system...

Blog

Essential steps for pharma software compliance in the operational phase

In the pharmaceutical industry, ensuring compliance in software systems is vital for safeguarding data integrity, patient safety, and regulatory adherence....

Blog

How to avoid non-compliance in the pharmaceutical industry

Over the years the pharmaceutical industry has become one of the most highly regulated, second only to the nuclear and aerospace industries. The...

Blog

Nitrosamine Impurities in Medicinal Products: Risks and Regulatory Insights

The emergence of nitrosamine impurities In June 2018, regulatory authorities worldwide became aware of the presence of the nitrosamine ...

Blog

What is a medical device? Key definitions and regulations around the world.

What is a medical device? This crucial question often arises when bringing medical devices to market. Determining whether your product qualifies as a...

Blog

What Makes Usability Testing Crucial for Near-Patient and Self-Testing Devices under IVDR?

Blog

When does Annex XIV apply in Performance Studies, and what key documentation is needed for compliance?

Blog

5 Key Toxicological Monitoring Tests for Regulatory Compliance

In an era where product safety and quality assurance are paramount,toxicological monitoring studieshave become essential for companies across industries....

Blog

Pharmacovigilance (PV) Safety Databases: Why They Matter and How to Choose the Right One

Pharmacovigilance is a cornerstone of patient safety and public health, ensuring that the benefits of medicines continue to outweigh their risks. Central to...

Blog

How to define your Clinical Performance Strategy?

1. Start with a clear intended purpose A strong clinical performance strategy begins with a well-defined Intended Purpose. This...

Blog

Understanding REACH Registration for Chemicals in Pharma

What is REACH, and Why is it Important for Pharma and Life Sciences?

Blog

Sterilization Validation: A Practical Guide to Ensuring Safety and Compliance

Sterilization validationis a vital process in the healthcare and pharmaceutical industries. It ensures that sterilization methods are not just...

Blog

15 Years of ATMPs – Reflecting on the Past, Shaping the Future

The Scientific Symposium on Advanced Therapy Medicinal Products (ATMPs), organized by the Committee for Advanced Therapies (CAT), marked a significant...

Blog

Status of the medical device regulatory landscape: An interview between QBD Group and Irdeto

On 22 May 2023, Irdeto and QBD Group sat down to discuss the developments of the medical device regulatory landscape. This is the transcribed...

Blog

Maintaining Validation Excellence: Continuous Improvement Through Periodic Validation Reviews in Pharma

Blog

Technovigilance in Action: Safeguarding Health with Post-Market Surveillance of Medical Devices

With rapid advancements in medical technology reshaping healthcare, new devices and innovations are emerging faster than ever before. From innovative...

Blog

Why Combining Scripted and Unscripted Testing Boosts Your CSV Strategy

Imagine your pharmaceutical company has rolled out new software to manage your drug manufacturing processes, believing the system was fully validated....

Blog

The Rise of Knowledge Process Outsourcing in Drug Safety: Smarter Outsourcing for Safer Healthcare

As healthcare and patient safety become more important than ever, pharmaceutical companies are totally rethinking how they handle data and keep track of...

Blog

Stay Ahead of Compliance: How to Effectively Manage Your Yearly Audits

In the pharmaceutical and medical device industries, maintaining compliance with regulatory standards is crucial for ensuring product quality and...

Blog

Mastering EU Product Information: The Role of the EMA’s Linguistic Review Process in Centralised Procedures

For Medicinal Products, the Product Information (PI) is a key document that provides a summary of officially approved information for Healthcare...

Blog

Accurate but appealing: How our scientific copywriters and designers collaborate to create captivating content

The life sciences landscape is vast, complex, and rapidly changing, so it can be hard to navigate. Valuable knowledge and ground-breaking...

Blog

Outsourcing Internal Audits: Benefits and Process Optimization in Your Pharma Company

In the dynamic healthcare industry, maintaining efficiency and compliance isn’t just a necessity—it’s a strategic advantage. Have you ever...

Blog

Why scientists turn to communication: unlocking benefits for Life Sciences companies

Scientists outside of science Many scientists catch the research bug as children. For some, the inciting incident was the gift of a...

Blog

The Risk of Benzene Contamination in Drug Products: What Manufacturers Need to Know

Benzene is a well-documented human carcinogen, and its presence in drug products poses a significant health risk. Benzene contamination can arise from...

Blog

Friability and disintegration for oral solid dose forms: the forgotten tests

Friability and disintegration testing are often overlooked during pharmaceutical development or testing; however, they play a certain role in getting...

Blog

Toxicological Assessment of Extractables and Leachables (E&L)

Ensuring the safety and efficacy of pharmaceutical products involves more than just the active ingredients. The materials used in packaging and delivery...

Blog

Analysing MHRA Performance: Clinical Trial and Amendment Applications in the UK

In 2023, assessment timelines for Clinical Trial Authorization (CTA) applications and substantial amendments by the MHRA were, in many cases, well beyond...

Blog

Article 31 Referrals in Pharmacovigilance: A Brief Overview

In the world of pharmaceuticals, ensuring the safety and efficacy of medicines is paramount. One crucial mechanism for maintaining these standards within...

Blog

How to Assess and Improve the Readability of Medicines: A Complete Guide | QbD Group

What is drug readability and why is it important? Readability refers to the clarity and ease with which a text can be read and understood. In the...

Blog

The Journey from Science to Story

So, you’ve made a huge breakthrough on a project you’ve been working on forever, or found that your drug can actually treat a whole other group of...

Blog

Analytical Method Transfer: Common Pitfalls and How to Avoid Them

Analytical method transfers (AMTs) are a critical step in the drug-development timeline. AMTs often occur due to sequential activities, such as...

Blog

Elevate Pharma Imports with EU GMP Annexes 16 and 21

In the world of pharma imports, maintaining Good Manufacturing Practice (GMP) standards is a shared responsibility that transcends borders. The...

Blog

The Holy Grail: Achieving Inspection Readiness

In a previous blog post, we talked about the various activities that take place during an inspection and how to deal with them as they occur....

Blog

Implementing PIC/S Standards in Hospital Cleanrooms: From Regulation to Application

Starting January 1, 2026, hospital pharmacies globally must comply with PIC/S standards for their pharmacy preparations, specifically requiring the...

Blog

Curb Your Enthusiasm – How to Avoid Rushing into Your Business Development Efforts with Unexpected Cost Consequences

Getting monetary value out of all your R&D efforts is key to the long-term success of your business. Launching products and services seems...

Blog

The Role of Artificial Intelligence (AI) in Pharmacovigilance in Europe: Advances and Legislation

The safety of medicines is a fundamental concern in the field of public health, and in Europe, pharmacovigilance plays a crucial role in ensuring...

Blog

In-House Devices (IHDs): The Impact of IVDR, ISO 15189:2022’s Update, and MDCG 2023-1 in the EU

In May 2022, the European Union (EU) ushered in the In Vitro Diagnostic Regulation (IVDR), marking a significant transition from the previous In...

Blog

Social Media in Pharmacovigilance: Harnessing Online Conversations for Drug Safety

Did you know millions of patients are already discussing medications and side effects online? Social media is revolutionizing pharmacovigilance,...

Blog

What to expect when being inspected?

In a previous blog post “Regulatory Inspection Readiness: A Proactive Approach to CAPA and Compliance” we talked about the steps to take after the...

Blog

Why do I still need to look at my QMS under the IVDR if it is ISO 13485 certified?

In the In Vitro Diagnostic (IVD) medical device industry, adhering to regulatory requirements is paramount to ensure IVDs are...

Blog

SCADA Automation in Pharma: Boosting Efficiency and Compliance

Imagine a world where countless operators meticulously monitored dials and switches, ensuring the precise production of life-saving...

Blog

Post-Market Success under IVDR: Prioritizing PMS & PMPF

Understanding IVDR requirements To leverage the transitional provisions and ensure compliance with IVDR, manufacturers must have...

Blog

Impact of PDE values on cleaning validation design in pharmaceutical manufacturing

Toxicology is fundamental throughout the drug life cycle, beginning with the evaluation of active substances in animals during the pre-clinical...

Blog

Safeguarding Drugs: Controlling Elemental Impurities (ICH Q3D)

Elemental impurities might not be the first thing you think of when it comes to drug safety, but they are crucial to understand. These impurities ...

Blog

The Crucial Role of Clinical Evidence in IVDR Compliance

In the In Vitro Diagnostic Medical Devices (IVD) manufacturing landscape, compliance with regulatory standards is paramount to...

Blog

Regulatory Inspection Readiness: A Proactive Approach to CAPA and Compliance

“Send” – After weeks of collaboration with the operations team, legal advisors, and experts, a detailed response along with Corrective and...

Blog

Why start building IVDR-compliant Technical Documentation now?

With the European Commission’s proposal for extending the transitional period for In Vitro Diagnostic Devices (IVDs), many...

Blog

Environmental Risk Assessments (ERA) in Pharma: Balancing Health & Environment | QbD Group

As we strive to improve our health with new medicines, it’s crucial we don’t forget the impact these advances could have on the environment. The...

Blog

Understanding the European Commission’s proposal for extending the transitional period for IVDs | QbD Group

In recent discussions, the European Commission’s proposal for extending the transitional period for In Vitro Diagnostic medical...

Blog

Drug-Device Combination Products and Article 117: How to Stay Compliant?

With the 2017 Medical Devices Regulation (MDR) fully operational from May 26, 2021, Article 117 has brought significant changes. It now requires that the...

Blog

FDA’s QMSR Introduction: Aligning Device CGMP Regulations with ISO 13485:2016

On January 31, 2024, the US Food and Drug Administration (FDA) published its long-anticipated final rule to amend its existing medical device good...

Blog

Patient Support Programs: Enhancing Patient Care through Pharmacovigilance

Patient Support Programs (PSPs), as outlined by the Good Pharmacovigilance Practices (GVP) Module VI, represent an organized system where marketing...

Blog

IVDR Transitional Extension: Why full speed ahead is still the best strategy

In the dynamic landscape of medical device regulations, the recent proposal by the European Commission to extend the transitional...

Blog

A Deeper Dive into the MHRA Good Pharmacovigilance Practice (GPvP) Inspection Metrics and Findings

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has been conducting Good Pharmacovigilance Practice (GPvP) inspections since 2003. Any...

Blog

Declaration of Equivalence for Medical Devices under the MDR

With the Medical Device Regulation (MDR 2017/745) being more stringent than the previous European Medical Device Directive (MDD) or the Active...

Blog

Impact of the AI Act on the MedTech and Life Sciences Industry

The AI Act was formally adopted by the full European Parliament on 13 March, and we have reviewed the current text to form our initial impressions of the...

Blog

The Impact of EU IVDR on Clinical Trials

We are pleased to share this meaningful article by two of our senior RA IVD consultants, Pieter Bogaert and Anne Paulussen, recently featured in RAPS...

Blog

MHRA to Launch RegulatoryConnect Portal in the UK: A New Era in Regulatory Management

During a webinar held on March 12, 2024, they unveiled the features of Release 1 of this innovative portal, previously known as the “RMS” or “Regulatory...

Blog

ICH Q2(R2) Validation of Analytical Procedures: An Overview of the Revised Guideline

Introduction Did you know that the precision of analytical methods directly influences the safety and efficacy of pharmaceutical products? Understanding...

Blog

How to create a GMP-Compliant Stability Protocol?

Stability testing forms the cornerstone of pharmaceutical quality, ensuring that medicinal products retain their safety, efficacy, and quality throughout...

Blog

Digital Therapeutics in the UK: The Post-Brexit Landscape

In earlier blog posts, we spotlighted the EU member states – Germany, Belgium, and France – and their adoption of the fast-track procedure for...

Blog

Exploring the U.S. Regulatory Framework for Mobile Health

U.S. Basic Requirements for DTx Products Subject to the U.S. Health Authority (FDA) regulations, specifically under ‘CFR Title 21...

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Toxicology Challenges in Pharma: How to Address Them?

Toxicology plays a pivotal role in the pharmaceutical industry, focusing on mitigating the adverse effects of substances on living organisms and their...

Blog

Mobile Health Ascending and the WHO’s Global Strategy on Digital Health

Digital therapeutics (DTx) represent an exciting frontier in healthcare, leveraging clinically validated digital technologies to enhance health and...

Blog

MDR Certification for Legacy Devices: Integrating Clinical Evidence for Compliance

Medical Devices CE certified under the European Medical Device Directive (MDD) or the Active Implantable Medical Devices Directive (AIMDD), are frequently...

Blog

Digital Therapeutics (DTx) in Germany: Pioneering “Deutsche Gründlichkeit” with Quality by Design

Germany has always been renowned for its meticulous attention to detail, often described by the term ‘Deutsche Gründlichkeit’. It’s no wonder then,...

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The DTx Landscape in Belgium, France, and Their Inspiration from the German Model

All Digital Therapeutics (DTx) must adhere to the EU’s foundational CE marking requirements as detailed in our blog post on the ‘ EU regulatory landscape...

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Pharmacovigilance (PV) Audits: importance, process, and challenges

In healthcare, safeguarding patient safety and upholding the integrity of pharmaceutical interventions are paramount. Enter pharmacovigilance (PV), a...

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Quality Audits Management: Quality Audits managed according to QMS

The Quality Audits should be managed according to the Quality Management System requirements , which should include: A risk-based planification...

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Quality and Regulatory Affairs: Key Elements of a Robust QMS in Pharma for Compliance and Success

In the complex and highly regulated world of pharmaceuticals, thesynergy between Quality and Regulatory Affairsis not just crucial, it’s indispensable....

Blog

The Rise of Mobile Health: Taking a Closer Look at the EU Regulatory Landscape

In a landscape marked by escalating healthcare expenses and budgetary restrictions, mobile health (mHealth) has emerged as a game-changer. Endorsed by the...

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Continuous manufacturing in the pharmaceutical industry: enhancing drug production

A significant shift towards continuous manufacturing (CM) is currently underway in the pharmaceutical industry. Unlike the more commonly used batch...

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Anticipate the Notified Body Rush: Ensure Timely MDR/IVDR Compliance

The rules outlined in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are crucial in ensuring patient safety and granting...

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MHRA’s International Recognition Procedure Post Brexit: Navigating Medicinal Product Registration in the UK

One of the initial changes implemented by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) following Brexit was introducing a...

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Understanding Software Medical Devices: Navigating the EU Regulations and Clinical Evaluations

Software Medical Devices (or Medical Device Software, as it is generally referred to in the EU), is often mistaken to be the same as Software As Medical...

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CE approval for Medical Devices under MDR: key requirements for your device class

Conformity assessments for CE approval As indicated on the website of the European Commission, a medical device can only be placed on the EU...

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Qualifying a new GMP facility: from pitfalls to best practices

In pharmaceutical production, a GMP (Good Manufacturing Practices) facility stands as a testament to stringent quality control and precision....

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Navigating Project Complexities: QbD’s Project Management Process for Qualification and Validation Projects

In the world of life sciences, ensuring the safety and efficacy of products is paramount. Qualification and validation projects play a pivotal role...

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Importing medicinal products into the EU? A brief guide to EU GMP compliance.

In an era of increasing globalization, the pharmaceutical landscape is undergoing significant changes. This blog post offers a structured insight...

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Computer Software Assurance (CSA) in Pharma Industry: First Steps to move from CSV to CSA

In the rapidly evolving pharmaceutical industry, computerized systems play a vital role in drug development, manufacturing, quality control, and...

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Understanding plasmids: small molecules with big implications

Plasmids are used in various research and biotechnology applications, such as gene therapy, vaccine development, and recombinant protein production.

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Oncolytic viruses: the use for cancer immunotherapy

Immunotherapy has become an important therapeutic alternative to surgery, chemotherapy, and radiation in the fight against cancer. Oncolytic viruses

Blog

Paperless Validation in Pharma: embrace the future

Nowadays, pharmaceutical companies have an ever-increasing number of equipment, automation activities, and computerized systems to streamline their...

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GMP-compliant design of climate or stability chambers: the key to ensuring product integrity

Stability testing serves as the backbone of regulatory compliance for pharmaceutical companies, providing crucial insights into the durability and...

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4 Factors Influencing the Stability of Medicinal Products

Ensuring the stability of medicinal products is crucial for maintaining their effectiveness and safety throughout their shelf life. Numerous factors come...

Blog

State Of The Art Literature Review – Process and Documentation

A comprehensive, objective, and thorough systematic literature review to describe the general State of the Art and identify all relevant clinical safety,...

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Digital health in pharma: revolutionizing the industry from R&D to patient care

Digital health in pharma is not just an emerging trend; it’s shaping the future of the pharmaceutical industry. This evolution is altering the healthcare...

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Mastering Cleanroom Qualification: navigating the latest regulatory updates

In 2022, significant updates were made to the main standards that impact the qualification of cleanrooms. These updates include: {% module_block...

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Computerized System Validation in clinical trials: key considerations

Computerized systems have become an integral part of clinical research, from data collection to analysis and reporting. However, ensuring the accuracy,...

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State of the Art (SOTA) Literature Review – What, Why, When, and Who?

State of the Art (SOTA) literature review is part of the clinical evaluation process of a medical device, which is defined as an ongoing collection,...

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The Importance of Stability Testing in Pharmaceutical Development

Stability testing plays a crucial role in the development of medicinal products, ensuring that they maintain their quality, safety, and efficacy throughout...

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Pharma 4.0: The Future of Pharmaceutical Manufacturing

Industry 4.0 refers to the fourth industrial revolution, and within the pharmaceutical industry, there is a specific term called Pharma 4.0. It involves...

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Clinical Literature Review – Common Gaps and Hurdles to Take

To get and maintain market approval in the EU (CE marking under MDR), state-of-the-art (SOTA) literature review is part of the process and mandatory for...

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EudraLex Volume 4 Annex 11: compliance checklist and future prospects

What is EudraLex Volume 4 Annex 11? EudraLex Annex 11 serves as a reference document within the European Union‘s pharmaceutical industry. It provides...

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A Deep Dive into Clinical Trials Regulations: Shifts and Strategies in the UK and EU

The last two years have seen significant changes in the approval management of clinical trials. In the UK, the Combine Review system became mandatory...

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The EU Commission Proposes a General Reform of Pharmaceutical Legislation – What it Means for Patients and the Industry

On 26 April 2023, the European Commission adopted a proposal for a new Directive and a new Regulation that revise and replace: the existing general...

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How to keep computerized systems in the operational phase?

Computerized systems play a crucial role in the life sciences, as these systems are used in daily activities such as data management, key processes, and...

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MDR transition: how to plan MDR compliance for your Medical Device?

In June 2022, concerns were expressed that severe challenges related to the implementation of Regulation (EU) 2017/745 on medical devices (MDR) would...

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Types of Medical Writing: Introduction to the Art of Medical Writing in Healthcare

Nowadays, regulations on medical devices and medicinal products have very strict expectations on documents outlining the benefits and performance and...

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Automated software testing for the GxP world

Automated software testing is becoming increasingly crucial in the GxP world, where Pharma 4.0 is the future, the EU MDR is asserting its influence, and...

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Analytical Method Validation: are your analytical methods suitable for intended use?

What is Analytical Method Validation? Analytical method validation is a critical process in the pharmaceutical, biotechnology, and food industries...

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ILAP: Introduction to the UK’s Innovative Licensing and Access Pathway

In order to give patients quicker access to cutting-edge treatments and therapies, the UK government introduced a pathway in 2021 called “Innovative...

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MHRA GMDP Symposium: key insights, trends, and best practices

The Medicines and Healthcare Products Regulatory Agency ( MHRA) Good Manufacturing and Distribution Practice (GMDP) symposium is a highly anticipated...

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What is the Agile model in Computerized System Validation?

Pharmaceutical, clinical, MD, and IVD companies pursuing robustness in their software validation activities can use either the V-model or the Agile model

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EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products – Summary and first insights

EU GMP Annex 1’s revision – the 2022 update to ‘ Manufacture of Sterile Medicinal Products‘ – aimed to eliminate ambiguities and inconsistencies while...

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MDR Annex XVI: products with non-medical purpose — Compliance and Common Specifications (CS)

Annex XVI of the MDR EU 2017/745 lists products (6 categories) without an intended medical purpose that now fall under the MDR. Manufacturers of these...

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UK’s medicines regulator announces IT roadmap

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently implemented a new organisational structure which aims to meet the additional...

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7 key areas to focus on during internal or supplier audits

Regulatory agencies require internal and supplier auditsin the pharmaceutical and medical device industry to ensure products are safe and effective....

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8 steps to successfully respond to non-conformities in an inspection report

Pharmaceutical companies are often inspected by competent authorities to verify the manufacturer’s compliance with regulatory requirements to ensure...

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Introduction to Digital Health in Clinical Trials

Digital technology is transforming the way clinical trials are conducted, offering new opportunities to improve patient experience, data quality, and trial...

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What is the GAMP 5 V-model in Computerized System Validation?

Using software for your life sciences operations requires high integrity and security in the data processing. Your computer systems must be designed to...

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Essential Documents in Clinical Investigations with Medical Devices: a brief overview

Are you performing clinical research with medical devices? In this blog post, we provide a brief overview of essential documents required during a...

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UDI for software: how to mark your MDSW with a UDI?

We recently published a blog post about Unique Device Identifiers (UDI). While this blog post briefly explains what a UDI is and how to implement it on...

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The European Parliament adopts proposed amendment to Medical Devices Regulation 2017/745 (MDR) to extend transitional deadlines for legacy Medical Devices

The European Parliament has adopted the proposal to extend the transitional period for legacy devices (i.e. those covered by a certificate or...

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Qualification of laboratory equipment: key considerations and challenges

The introduction of a new product into your company’s portfolio may require expanding your existing laboratories or even building a new laboratory to...

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Back to Blog Are systems in compliance with ISO 80002-2 if we follow the guidelines described in GAMP5?

In the world of life sciences, an endless stream of compliance documents is thrown around. It’s no different for computerized systems. It’s not always that...

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Medical Device and IVD industry trends for 2023

At the beginning of yet another new year, it is always interesting to take a moment to reflect on the growth and future prospects within the life...

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Change Control Management: how to keep your systems compliant?

Change control management is an essential part of any quality assurance system. It enables us to maintain control of the validated status and always be in...

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The Advent of Artificial Intelligence and Machine Learning in Medical Devices

Artificial intelligence (AI) and machine learning (ML) are on the rise in our society, changing the landscape of our daily lives, just think about...

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Medical Device development: the importance of Design Transfer and Process Validation

Bringing a Medical Device to market involves many hurdles, including medical device design and medical device development. While the design and development...

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Annual Product Quality Review (APQR / PQR) in Pharma: importance, benefits & challenges

Current regulations require written documentation for all existing products in the company; this documentation is known as the A nnual Product Quality...

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What is digital health? Exploring the landscape and future opportunities.

‘Digital health‘ is on the rise. It’s a term we use more and more often. But what is digital health? What does it mean? After some research, we find all...

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21 CFR Part 11 compliance checklist: does your system comply?

In the post-COVID pharmaceutical landscape, electronic records and signatures are indispensable, guided by the 21 CFR Part 11 compliance framework. This...

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Team up with a Contract Research Organization (CRO) dedicated to medical devices to boost your clinical research strategy

Are you excited to bring your brand-new medical device to market? As you navigate the challenging product lifecycle process, one key aspect will be...

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Finding your way through the maze of international, European, and harmonized standards for medical devices

ISO, IEC, EN ISO… References to standards can be confusing. What is the difference between these standards? What are harmonized standards and what is their...

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AI and machine learning validation: strategies and examples

In the life science industry, Artificial Intelligence (AI) and Machine Learning (ML) validation have been the buzzwords of the past year. Every...

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What is the purpose of Periodic Reviews in CSV?

Current regulations require that manufacturing processes in the pharmaceutical industry be validated, and once validated, they must be continuously...

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The importance of high-quality gas distribution networks for critical process gases, even in the early development phase

Although no single best practice, standard, or guideline has been specifically enforced, competent authorities, such as the FDA, are increasingly...

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GAMP 5 guide 2nd edition: what’s new?

GAMP 5, which stands for “Good Automated Manufacturing Processes”, is an approach that has been widely used in life science industries for validating...

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Why self-inspections or internal audits are essential for your QMS

Any company in the pharmaceutical or medical device industry with a certified GMP, GDP or ISO 13485 Quality Management System must conduct self-inspections...

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The regulatory pathway for your custom-made medical device

Custom-made medical devices are the odd ones out when it comes to the Medical Devices Regulation (EU) 2017/745. The MDR mentions “other than...

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Medicine advertising in Belgium: a brief regulatory overview

In Belgium, medicine advertising is subject to specific legislation. The objective is to ensure the rational use of medicines, based on accurate and...

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PRRC under MDR and IVDR: meaning, requirements, and responsibilities

PRRC: meaning of this new role under MDR and IVDR The Person Responsible for Regulatory Compliance or ‘PRRC’ is a mandatory role introduced by the ...

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6 common myths about life sciences consultancy

A job in life sciences consultancy offers plenty of challenges, variety, career opportunities, and growth, but it is still shrouded in myth and mystery

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Compressed gases in pharmaceutical manufacturing: best practices in microbial monitoring

Compressed gas standards The latest draft of Annex 1, Manufacture of Sterile Medicinal Products, introduced the concept of a “contamination...

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Data migration in CSV: definition, purpose, and best practices

Ever wondered why it is necessary – and sometimes absolutely essential – to perform a Data Migration in computer systems, applications or software,...

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New GMP Annex 21 ‘Importation of Medicinal Products’ – Are you ready?

Current EU regulatory framework for MIA holders In recent years, medicinal products for the EU market are increasingly manufactured outside the EU ...

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What is decommissioning in CSV?

Changes in business needs or technology are inevitable. They often lead to the retirement or “decommissioning” of computerized systems. ERP systems, for...

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Clinical Evaluation Report (CER): a must-have for all medical device classifications

Clinical evaluation of a medical device – defined as an ongoing collection, generation, appraisal, and analysis of clinical data related to your device –...

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Clinical Evaluation Plan (CEP): roadmap of the clinical evaluation strategy

Clinical evaluation of a medical device is central to obtaining and maintain ing market approval in the EU. For planning and documenting...

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How to use electronic signatures in regulated industries?

During the pandemic, electronic signatures gained tremendous importance for companies in heavily regulated industries. After all, a correctly...

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EDQM and the CEP of the future

Before marketing a medicinal product, pharmaceutical companies must obtain a marketing authorization (MA) from the respective licensing authority. In...

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CAR-T cell therapy: main components, manufacturing, and prospects

CAR-T cell therapy, a groundbreaking advancement in the pharmaceutical industry over the last 20 years, exemplifies the innovative strides made in areas...

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What is EUDAMED and what new requirements should medical device companies take into account?

The new medical device regulations and the associated implementation of EUDAMED should give the general public access to relevant information about...

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GAMP categories for computerized systems: what are they and what are they for?

New to validating computerized systems? If so, it might be difficult to get started on this type of validation. Why? Because, even if you have experience...

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3D printing medical devices: enabling patient-specific solutions for a better quality of care

Additive manufacturing, particularly 3D printing, has attracted strong attention of the medical devices and medical community at large over the past...

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Dendritic (DC) cells: effective sentinels for immunotherapies

Dendritic cells (DCs) are crucial cells in the initiation and regulation of the adaptive immune response. These leukocytes form a link between the...

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Natural Killer (NK) cells: a major breakthrough in the field of ATMPs

Natural Killer cells or NK cells are large lymphocytes (white blood cells) that play a crucial role in our innate immune system. The innate immune system,...

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From IVDD to IVDR: avoid these pitfalls to get your CE marking in time

In vitro diagnostic (IVD) medical devices (Manufacturers | Internal Market, Industry, Entrepreneurship and SMEs (europa.eu)) have gained a lot of...

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Medical device combination products: what regulations should you apply before marketing them in the EU?

In recent years, more and more medicinal products (MP) are used in conjunction with a medical device (MD). These are called “ combination products”....

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IVDR classification of in-vitro diagnostic medical devices: a brief guide for manufacturers

In vitro diagnostic medical devices (IVDs) have long been a part of our healthcare industry. Recently, however, the use of IVDs has increased drastically....

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MDR impact on MDSW: what has changed from MDD?

Are you aware that the introduction of MDR may have affected your CE-marked medical software (MDSW)? Or will affect the CE marking of your first or next...

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Medical Device Industry Trends: on wearables, AI, POC testing, IoT, and more

One of our previous blogposts discussed medical device industry trends and innovations. Since then, more recent data on the number of patent...

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Unraveling Artificial Intelligence in Medical Devices: what do we know so far?

Artificial Intelligence is the IT word in Medical Devices nowadays when it comes to software development. Every medical device company wants to fling...

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SaMD versus MDSW: what’s the difference between Software as a Medical Device and Medical Device SoftWare?

Nowadays, digital healthcare is taking an increasingly important place in the medical world through medical software, image processing, diagnostic support,...

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5 consequences of Brexit when selling medical devices in the UK

Needless to say, Brexit has had a major impact on numerous businesses. And that was no different for the life sciences industry. In this article, we...

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ATMPs: translating the expertise into a GMP process

In the field of regenerative medicine, advanced therapy medicinal products (ATMPs) represent the next generation of medicines. It is, however, not...

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Why Medical Device Risk Management is as complex as it is crucial

Risk management iskey to promoting the safety of medical devices. So it’s with good reason that the new European medical device regulations MDR...

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Clinical Trials for ATMPs: which challenges to overcome?

T he global regenerative medicine market, including  direct-to-consumer stem cell therapy , is expected to reach $5.6 billion by 2025, according to a...

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10 things you should know before validating Computerized Systems

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Smart factories: How digital twins can strongly improve your ATMP manufacturing processes

Industry 4.0 is currently revolutionizing the design, manufacturing and services of healthcare applications. It includes the automation and...

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From idea to post market surveillance: the phases of the medical device lifecycle

Ideation and feasibility phase Every medical device invention, from a simple syringe to an advanced CT scanner,...

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Why QP challenges in ATMPs are different & what you need to know

QP challenges in ATMPs Advanced Therapeutic Medicinal Products are – by definition – ‘advanced’. In order to meet the new scientific progress,...

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How do you reduce the Cost of Goods, which is key to affordable ATMPs?

Today, only 18 cell and gene therapies have made it to the FDA approved therapies list.Only 14have been approved for the European market. This means...

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What you need to know to make your medical device UDI-ready in time

The EU Medical Device Regulation 2017/745 (MDR) and EU In Vitro Diagnostic Regulation 2017/746, (IVDR)bringnew obligations with them. One of them is...

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The key role of Regulatory Affairs in the pharmaceutical industry: from development to commercialization

Regulatory Affairs plays a crucial role in the pharmaceutical industry, especially during drug development: a lengthy, complex, and extremely costly but...

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Post-Market Surveillance of Medical Devices

A short introduction and overview of the requirements In 2017, the European Commission released the new Medical Device Regulation (MDR) that will replace...

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Is your ATMP platform robust enough to deal with material input variability?

Do you want to distinguish starting materials used for ATMPs from those used for transplants or transfusions? This distinction is made based on how the...

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Quality by design methodology for the pharmaceutical industry

How to guarantee medicine quality and patient safety To explain the quality by design methodology, it’s important to first pay attention to how the quality...

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Automation Pyramid – FAQ

What does an automation pyramid entail? An automation pyramid visualizes the integrated layers of technology used in manufacturing or industry combined...

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What to focus on when validating a computer system? (3)

GxP Processes At first glance, business processes are not important from a regulatory point of view. However, it is necessary to assess them if the...

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What to focus on when validating a computer system? (2)

When categorizing, GAMP5® takes two main aspects of a system into account: the complexity and the inherent risk. The more standard and tested software is, the...

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ATMP manufacturing for the market: main hurdles to be tackled to ensure a high-quality end product.

Hurdles to be taken As ATMPs progress towards commercialization, engineering challenges increase along with the increased number of patients and collection...

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What to focus on when validating a computer system

In our first blog we discussed the definitions of validation and computerized systems. Assessing the health of the system means checking whether the system...

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Anything you need to know about ATMPs: FAQ

What is the definition of ATMP? From the website of EMA: Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on...

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ATMPs in a nutshell: what you should know about classification, quality and go to market

Advanced therapy medicinal products (ATMP) is the group of therapies in which we use cells, genes, engineered tissues and combinations of the above with...

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Artificial Intelligence in Advanced Therapy Medicinal Products

What are ATMPs and what are the challenges? According to the European Medicines Agency (EMA), ATMPs are ‘medicines for human use that are based on genes,...

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Computer Systems: is Assurance the new Validation?

The past of Computer Systems Validation has served us well and provided us with the foundation of where we are today. But at some point, the past can become a...

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Market release of vaccines: European Union versus the United States of America

First of all, let’s take a look at the manufacturing flow of vaccines. The production process consists of various stages. It all starts with the raw...

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Technical Writing in Pharma and Biotech: Essential Tips

Imagine guiding someone through Excel’s myriad functions in a written manual. Where to begin? With basics like opening the program and creating...

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Serialization in the EU can become a competitive advantage if you dare to innovate

Falsified medicines could seriously harm the health of patients and may even put their lives at risk. A counterfeit product can contain wrong dosages,...

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EU GMP Annex I: Are we ready for the challenges posed after its revision?

After months of revision and many questions raised, it now appears that the time is coming to implement the new requirements contained in the revision of...

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Pioneering with Artificial Intelligence to make personalized cell therapy more accessible

Several scientific and clinical breakthroughs of our past decade show that Advanced Therapy Medicinal Products (ATMP) will revolutionize 21st century...

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Updating Good Clinical Practice E6(R2)

Every day, patients around the world participate in clinical trials. Their contributions are crucial, as they ensure the progress of vital research....

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Preparing for growing challenges in pharmaceutical serialization

Serialization is rapidly emerging in the pharmaceutical world. To fight counterfeit drugs, more and more governments demand that every single sales...

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Antleron & QbD team up to create a landslide in healthcare

Some encounters have big consequences. When QbD’s CEO Bart Van Acker met Antleron co-founder Jan Schrooten at a Flanders.bio event, one thing soon led to...

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Data integrity in the pharma industry – a short introduction

Over the last couple of years, the data integrity topic has received more and more attention. Recently, the American Food and Drug...

Regulatory update

PMS Statutory Instrument + MHRA Guidance released (Great Britain)

The Medicines and Healthcare products Regulatory Agency (MHRA) has released a guidance to assist medical device manufacturers in preparing for the new PMS...

Regulatory update

New MDCG Guidance documents released

MDCG 2024-2 rev 1, updates the procedures for revising the European medical device nomenclature, now including a table for the ad hoc procedure aligned with...

Regulatory update

Expert Panel Advice on SARS-CoV-2

The expert panel provided the following advice to the questions raised:

Regulatory update

New revision to EMA Guidance documents released

Both documents, Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics and ...

Regulatory update

New revisions of the Preliminary Assessment Review templates, forms and annexes

The documents are available in the Notified Body section of the MDCG Guidance webpage. The application forms are to be used by conformity assessment bodies...

Regulatory update

Second revision to MDCG 2023-3 Guidance document released

MDCG 2023-3 Rev. 2: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

Regulatory update

New MDCG 2020-16 Revision 3 Guidance Documents Released

MDCG 2020-16 Revision 3: Guidance on classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

Regulatory update

MDCG 2022-3 Rev.1 released

Notified bodies are required to verify product batches of class D IVDs. Therefore, manufacturers should forward to notified bodies the reports on tests carried...

Regulatory update

Revision of MDCG 2019-13 released

MDCG 2019-13 Rev.1: Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation

Regulatory update

New MDCG 2024-16 form released

On December 6th, 2024, the Medical Device Coordination Group (MDCG) released a Manufacturer Information Form on Interruption or Discontinuation of Supply of...

Regulatory update

New MDCG Guidance document released on the implementation of the Master UDI-DI solution for contact lenses

On November 26th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the implementation of the Master UDI-DI solution for contact...

Regulatory update

New MDCG Guidance document released

On December 2nd, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the publication of the clinical investigation reports and their...

Regulatory update

New Q&A released on the gradual roll-out of EUDAMED

On November 21st, 2024, the Medical Device Coordination Group (MDCG) released a Q&A on the gradual roll-out of EUDAMED. This document provides a Q&A related to...

Regulatory update

EMA launched a new draft guideline on risk management requirements for elemental impurities in veterinary medicinal products

Last October, the EMA launched a new draft for public consultation on the risk assessment of elemental impurities in veterinary products, which will replace...

Regulatory update

MDCG 2023-3 Rev 1 released

On November 11th, 2024, the Medical Device Coordination Group (MDCG) released its first revision (MDCG 2023-3 Rev 1) of the questions and Answers on vigilance...

Regulatory update

MDCG 2024-13 and MDCG 2022-5 Rev 1 released

On October 29th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance (MDCG 2024-13) on the regulatory status of ethylene oxide (EtO)...

Regulatory update

New Q&A on the obligation to inform in case of interruption or discontinuation of supply

On October 30th, 2024, the Medical Device Coordination Group (MDCG) released a Q&A on the obligation to inform in case of interruption or discontinuation of...

Regulatory update

First Revision of MDCG 2021-25 Released

Application of MDR requirements to “legacy devices” and to devices placed on the market prior to 26 May 2021This guidance outlines how MDR requirements relate...

Regulatory update

MDCG 2024-12 released

It includes detailed sections on corrections, root cause analysis, corrective and preventive actions, and actions for verification of effectiveness. The...

Regulatory update

MDCG 2024-11 released

Regulatory update

Newly Listed Harmonized Standards

EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) is now a harmonised standard under both the...

Regulatory update

Revised MDCG 2021-4 Guidance Documents Released

Regulatory update

The FDA releases revision of guidance regarding Control of Nitrosamine Impurities in Human Drugs

What’s new?

Regulatory update

New MDCG Guidance Documents Released

MDCG revises Q&A on importers, distributors' requirements (MDCG 2021-27 Revision 1), EU Regulations 2017/745 & 2017/746.

Regulatory update

Publication of Amendments to Regulation (EU) 2024/1860

Regulation (EU) 2024/1860 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and...

Regulatory update

MDCG: First Revision on the Guidance on Standardisation for Medical Devices

MDCG 2021-05 Revision 1: Guidance on standardization for medical devices The scope of this document is to provide guidance on different aspects related to...

Regulatory update

New Update of Appendix 1 of the Nitrosamines Guideline

What’s new? In this update, the Acceptable Intake (AI) values for nitrosamines related to the use of DIPEA (NDIPA and NEIPA) and NMP (NMBA) have been...

Regulatory update

MDCG 2022-13 Rev.1 – Designation, Re-assessment, and Notification Process for Conformity Assessment and Notified Bodies

MDCG 2022-13 Revision 1 – Designation, re-assessment and notification of conformity assessment bodies and notified bodiesThis guidance is intended for use by...

Regulatory update

Urogynaecological Surgical Mesh Implants for Pelvic Organ Prolapse and Stress Urinary Incontinence Repair (MDCG 2024-1-5)

MDCG 2024-1-5 – DSVG 05 – Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary IncontinenceThe aim of this Device...

Regulatory update

Updated Guidance on MDR Surveillance: MDCG 2022-4, Revision 2

Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates...

Regulatory update

MDCG 2024-10: Clinical Evaluation Guidelines for Orphan Medical Devices

MDCG 2024-10 Clinical evaluation of orphan medical devicesThis document provides guidance to manufacturers and notified bodies on the clinical evaluation...

Regulatory update

New MDCG Guidance Documents Released: Key Updates and Insights

On May 15th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies. On May 15th, 2024, the Medical Device...

Regulatory update

New MDCG & Stakeholders Survey on MDR/IVDR Certifications and Applications Released by Notified Bodies

On May 17th, 2024, the European Commission released the survey results of the 8th Notified Body survey on certifications and applications under the MDR and...

Regulatory update

Latest Update on Appendix 1 of the Nitrosamine Guidelines

On 01/05/2024, the European Medicines Agency (EMA) rolled out an update to Appendix 1 (EMA/154403/2024 /Rev. 4) of the Nitrosamines Guideline. In this Appendix...

Regulatory update

EU Parliament Passes Groundbreaking Proposal

On April 25th, 2024, the European Parliament approved the proposal made in January 2024 by the European Commission for a Regulation amending Regulations...

Regulatory update

New EMA Guideline on Environmental Risk Assessment for Human Medicinal Products

New guideline from the European Medicines Agency (EMA) on the Environmental Risk Assessment of medicinal products for human use, accepted on February 15 and...

Regulatory update

New MDCG Guidance on Safety Reporting for Performance Studies of In Vitro Diagnostic Medical Devices under EU Regulation 2017/746 Released

On April 15th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document on safety reporting in performance studies of in vitro...

Regulatory update

New MDCG Guidance on Investigator’s Brochure Content for Clinical Investigations of Medical Devices

On April 17th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document on content of the Investigator’s Brochure for clinical...

Regulatory update

New MDCG Guidance Released: Detailed Instructions for Clinical Investigation Plans in Medical Device Studies

New MDCG Guidance documents released: Guidance on the content of the Clinical Investigation Plan for clinical investigations of medical devices. On March 12th,...

Regulatory update

New MDCG Guidance on Updating the European Medical Device Nomenclature (EMDN)

The Medical Device Coordination Group (MDCG) released a procedure for the updates of the European Medical Device Nomenclature (EMDN). The EMDN, as established...

Regulatory update

New MDCG Guidance Released: Device-Specific Vigilance Document

The Medical Device Coordination Group (MDCG) released a Device Specific Vigilance Guidance Document (DSVG) to harmonize vigilance reporting and provide...

Regulatory update

Newly Published Harmonized Standards for MDR and IVDR Compliance

On March 8th, 2024, “Commission Implementing Decision (EU) 2024/815 of March 6th, 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised...

Regulatory update

EU Council Endorses Proposal to Amend IVDR and MDR Regulations

The Council of the European Union officially endorsed without any changes the proposal to amend IVDR and MDR.

Regulatory update

Proposed Amendments to IVDR and MDR: Transitional Provisions, EUDAMED Roll-Out, and Supply Chain Interruptions

EU Commission proposes IVDR & MDR amendments: Eudamed rollout, supply interruption reporting, extended transitional provisions for certain IVDR devices.

Regulatory update

Comprehensive Overview of Language Requirements under IVDR/MDR for Medical Device Manufacturers

EU Commission published MDR and IVDR language requirement tables for medical device manufacturers, aiding compliance with linguistic regulations across Member...

Regulatory update

New EMA FAQ on medicinal products development and assessment involving a CDx

EMA released Q&A on biomarker-guided meds, excluding clinical trial approval and CDx conformity. Offers guidance for marketing authorization data generation. ...

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