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Sub-visible particles in pharmaceutical products: understanding EP General Chapter 2.9.19

Ensuring the safety and quality of injectable pharmaceutical products is critical, and one key aspect of this is preventing particulate contamination

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Analytical Method Transfer under GMP: tips & pitfalls

Analytical Method Transfers (AMTs) are a critical step in ensuring the reliable reproduction of validated analytical methods. These transfers occur...

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How QPs Verify GMP Compliance for Non-EU Manufactured Products

Qualified Persons (QPs) play a crucial role in ensuring that medicinal products imported into the European Union (EU) meet Good Manufacturing...

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Analytical Method Transfer: a practical step-by-step guide to compliance and efficiency

Did you know that performing an Analytical Method Transfer (AMT) can significantly benefit your laboratory? It’s a crucial process that allows...

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ICP-MS vs ICP-OES analysis: choosing the right elemental impurity testing method

Elemental impurities in medicinal products and excipients are a major concern for regulatory authorities. The ICH Q3D guidelines set clear...

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Establishing and Maintaining the Right Level of Clinical Evidence under the EU IVDR

We’re proud to highlight a new publication by Pieter Bogaert, PhD—senior RA IVD consultant at QbD Group—recently featured in RAPS Regulatory Focus. In...

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Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) under the MDR: Ensuring safety and performance

With the introduction of the Medical Device Regulation (MDR), the requirements for placing medical devices on the market have significantly increased....

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EU-QPPV registration and local pharmacovigilance contacts: what you need to know

In the European Union, ensuring the safety of human pharmaceutical products requires strict compliance with pharmacovigilance regulations. At the heart of...

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Pharmacovigilance Agreements (PVA) simplified: key requirements and best practices for compliance

Pharmacovigilance Agreements (PVA), also known as Safety Data Exchange Agreements (SDEA), are essential legal contracts that outline the responsibilities for...

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Container Closure Integrity Testing (CCIT): why it’s essential for pharmaceutical packaging

Imagine this: a life-saving drug reaches a patient, but due to a small, undetected defect in its packaging, the medicine is no longer sterile. The...

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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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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 ...

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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...

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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...

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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....

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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...

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

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

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What are the requirements for IVD Clinical Performance Studies Under IVDR and ISO 20916?

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....

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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...

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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...

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Understanding REACH Registration for Chemicals in Pharma

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

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Why is Clinical Performance key to a successful IVDR submission?

The In Vitro Diagnostic Regulation (IVDR) represents a major shift in the regulatory landscape for IVD manufacturers, placing significant...

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...

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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...

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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...

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

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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...

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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....

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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...

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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...

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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...

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....

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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...

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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...

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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...

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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...

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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,...

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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...

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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...

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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...

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Post-Market Success under IVDR: Prioritizing PMS & PMPF

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

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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...

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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 ...

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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...

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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...

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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...

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

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...

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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...

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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...

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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...

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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...

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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...

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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...

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...

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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...

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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...

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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...

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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...

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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...

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...

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...

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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...

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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...

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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 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....

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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 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...

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.

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

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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...

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...

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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...

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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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...

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 to...

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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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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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GMP Annex 21: key requirements for importing medicines into the EU

In recent years, medicinal products for the EU market have been increasingly manufactured outside the EU. While this trend is particularly noticeable in...

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...

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...

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,...

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...

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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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...

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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...

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...

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...

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...

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...

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...

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