What do you do when a healthcare professional emails your company about off-label use Or when a pati...

Balancing human health, regulatory compliance, and environmental protection is becoming increasingly...

Balancing efficiency, cost, and compliance is a growing challenge for organizations—particularly in ...

Next-Generation Sequencing (NGS) has revolutionized precision oncology. By enabling the simultaneous...

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In every Good Manufacturing Practice (GMP) laboratory, three priorities continuously compete for att...

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Annual Product Reviews (APR) and Product Quality Reviews (PQR) are essential for compliance in the l...

In clinical research, the success of a trial heavily depends on two key factors: recruiting enough e...

The In Vitro Diagnostic Regulation (IVDR) in the EU is widely considered one of the most rigorous re...

Effective site selection and qualification are the cornerstones of any successful clinical trial. By...

As pharma and biotech companies expand globally, one of the most underestimated challenges they face...

In the fast-paced world of biopharmaceuticals, innovation often means launching new products. But wh...

In today’s globalized and highly regulated supply chain, keeping pharmaceutical products safe and ma...

Picture this: you’re racing to get a promising new therapy from lab bench to patient bedside, only t...

Over the past few decades, the pharmaceutical industry has seen a dramatic shift in how regulatory s...

Since August 25, 2023, the pharmaceutical industry has been operating under a new standard for steri...

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Vaccines are among the most powerful tools in modern medicine, but monitoring vaccine safety doesn’t...

An Investigational Medicinal Product Dossier (IMPD) is a critical document required for clinical tri...

Cleaning validation plays a vital role in safeguarding patient health — particularly in multiproduct...

Audits play a central role in ensuring regulatory compliance, product quality, and operational integ...

With people, animals, and ecosystems more connected than ever, safeguarding animal health and veteri...

The COVID-19 pandemic wasn’t just a global health crisis — it was a wake-up call for how vulnerable ...

Drug packaging and manufacturing materials may seem inert, but they can release chemicals that affec...

In recent years, medicinal products for the EU market have been increasingly manufactured outside th...

Ensuring the safety and quality of injectable pharmaceutical products is critical, and one key aspec...

Analytical Method Transfers (AMTs) are a critical step in ensuring the reliable reproduction of vali...

Qualified Persons (QPs) play a crucial role in ensuring that medicinal products imported into the Eu...

Did you know that performing an Analytical Method Transfer (AMT) can significantly benefit your labo...

Elemental impurities in medicinal products and excipients are a major concern for regulatory authori...

We’re proud to highlight a new publication by Pieter Bogaert, PhD—senior RA IVD consultant at QbD Gr...

With the introduction of the Medical Device Regulation (MDR), the requirements for placing medical d...

In the European Union, ensuring the safety of human pharmaceutical products requires strict complian...

Pharmacovigilance Agreements (PVA), also known as Safety Data Exchange Agreements (SDEA), are essent...

Imagine this: a life-saving drug reaches a patient, but due to a small, undetected defect in its pac...

The Quality Audits should be managed according to the Quality Management System requirements , which...

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

In pharmaceutical operations, effective software compliance is vital for regulatory adherence, data ...

In the pharmaceutical industry, maintaining software compliance is a continuous process that extends...

In the pharmaceutical industry, ensuring compliance in software systems is vital for safeguarding da...

Over the years the pharmaceutical industry has become one of the most highly regulated, second only ...

In an era where product safety and quality assurance are paramount, toxicological monitoring studies...

Pharmacovigilance is a cornerstone of patient safety and public health, ensuring that the benefits o...

1. Start with a clear intended purpose A strong clinical performance strategy begins with a well-def...

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

The In Vitro Diagnostic Regulation (IVDR) represents a major shift in the regulatory landscape for I...

Sterilization validation is a vital process in the healthcare and pharmaceutical industries. It ensu...

The Scientific Symposium on Advanced Therapy Medicinal Products (ATMPs), organized by the Committee ...

With rapid advancements in medical technology reshaping healthcare, new devices and innovations are ...

Imagine your pharmaceutical company has rolled out new software to manage your drug manufacturing pr...

As healthcare and patient safety become more important than ever, pharmaceutical companies are total...

In the pharmaceutical and medical device industries, maintaining compliance with regulatory standard...

For Medicinal Products, the Product Information (PI) is a key document that provides a summary of of...

The life sciences landscape is vast, complex, and rapidly changing, so it can be hard to navigate. V...

In the dynamic healthcare industry, maintaining efficiency and compliance isn’t just a necessity—it’...

Scientists outside of science Many scientists catch the research bug as children. For some, the inci...

Benzene is a well-documented human carcinogen, and its presence in drug products poses a significant...

Friability and disintegration testing are often overlooked during pharmaceutical development or test...

Ensuring the safety and efficacy of pharmaceutical products involves more than just the active ingre...

In 2023, assessment timelines for Clinical Trial Authorization (CTA) applications and substantial am...

In the world of pharmaceuticals, ensuring the safety and efficacy of medicines is paramount. One cru...

What is drug readability and why is it important? Readability refers to the clarity and ease with wh...

So, you’ve made a huge breakthrough on a project you’ve been working on forever, or found that your ...

Analytical method transfers (AMTs) are a critical step in the drug-development timeline. AMTs often ...

In the world of pharma imports, maintaining Good Manufacturing Practice (GMP) standards is a shared ...

In a previous blog post, we talked about the various activities that take place during an inspection...

Starting January 1, 2026, hospital pharmacies globally must comply with PIC/S standards for their ph...

Getting monetary value out of all your R&D efforts is key to the long-term success of your busin...

The safety of medicines is a fundamental concern in the field of public health, and in Europe, pharm...

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

Did you know millions of patients are already discussing medications and side effects online? Social...

In a previous blog post “Regulatory Inspection Readiness: A Proactive Approach to CAPA and Complianc...

Imagine a world where countless operators meticulously monitored dials and switches, ensuring the pr...

Understanding IVDR requirements To leverage the transitional provisions and ensure compliance with I...

Toxicology is fundamental throughout the drug life cycle, beginning with the evaluation of active su...

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

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

“Send” – After weeks of collaboration with the operations team, legal advisors, and experts, a detai...

With the European Commission’s proposal for extending the transitional period for In Vitro Diagnosti...

As we strive to improve our health with new medicines, it’s crucial we don’t forget the impact these...

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

With the 2017 Medical Devices Regulation (MDR) fully operational from May 26, 2021, Article 117 has ...

On January 31, 2024, the US Food and Drug Administration (FDA) published its long-anticipated final ...

Patient Support Programs (PSPs), as outlined by the Good Pharmacovigilance Practices (GVP) Module VI...

In the dynamic landscape of medical device regulations, the recent proposal by the European Commissi...

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has been conducting Good Pharmacov...

With the Medical Device Regulation (MDR 2017/745) being more stringent than the previous European Me...

The AI Act was formally adopted by the full European Parliament on 13 March, and we have reviewed th...

We are pleased to share this meaningful article by two of our senior RA IVD consultants, Pieter Boga...

During a webinar held on March 12, 2024, they unveiled the features of Release 1 of this innovative ...

Introduction Did you know that the precision of analytical methods directly influences the safety an...

Stability testing forms the cornerstone of pharmaceutical quality, ensuring that medicinal products ...

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U.S. Basic Requirements for DTx Products Subject to the U.S. Health Authority (FDA) regulations, spe...

Toxicology plays a pivotal role in the pharmaceutical industry, focusing on mitigating the adverse e...

Digital therapeutics (DTx) represent an exciting frontier in healthcare, leveraging clinically valid...

Medical Devices CE certified under the European Medical Device Directive (MDD) or the Active Implant...

Germany has always been renowned for its meticulous attention to detail, often described by the term...

All Digital Therapeutics (DTx) must adhere to the EU’s foundational CE marking requirements as detai...

In healthcare, safeguarding patient safety and upholding the integrity of pharmaceutical interventio...

In the complex and highly regulated world of pharmaceuticals, the synergy between Quality and Regula...

In a landscape marked by escalating healthcare expenses and budgetary restrictions, mobile health (m...

A significant shift towards continuous manufacturing (CM) is currently underway in the pharmaceutica...

The rules outlined in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) ...

One of the initial changes implemented by the UK’s Medicines and Healthcare products Regulatory Agen...

Software Medical Devices (or Medical Device Software, as it is generally referred to in the EU), is ...

Conformity assessments for CE approval As indicated on the website of the European Commission, a med...

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In an era of increasing globalization, the pharmaceutical landscape is undergoing significant change...

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Immunotherapy has become an important therapeutic alternative to surgery, chemotherapy, and radiatio...

Nowadays, pharmaceutical companies have an ever-increasing number of equipment, automation activitie...

Stability testing serves as the backbone of regulatory compliance for pharmaceutical companies, prov...

Ensuring the stability of medicinal products is crucial for maintaining their effectiveness and safe...

A comprehensive, objective, and thorough systematic literature review to describe the general State ...

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In 2022, significant updates were made to the main standards that impact the qualification of cleanr...

Computerized systems have become an integral part of clinical research, from data collection to anal...

State of the Art (SOTA) literature review is part of the clinical evaluation process of a medical de...

Stability testing plays a crucial role in the development of medicinal products, ensuring that they ...

Industry 4.0 refers to the fourth industrial revolution, and within the pharmaceutical industry, the...

To get and maintain market approval in the EU (CE marking under MDR), state-of-the-art (SOTA) litera...

What is EudraLex Volume 4 Annex 11? EudraLex Annex 11 serves as a reference document within the Euro...

The last two years have seen significant changes in the approval management of clinical trials. In t...

On 22 May 2023, Irdeto and QBD Group sat down to discuss the developments of the medical device regu...

On 26 April 2023, the European Commission adopted a proposal for a new Directive and a new Regulatio...

In June 2022, concerns were expressed that severe challenges related to the implementation of Regula...

Nowadays, regulations on medical devices and medicinal products have very strict expectations on doc...

Automated software testing is becoming increasingly crucial in the GxP world, where Pharma 4.0 is th...

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In order to give patients quicker access to cutting-edge treatments and therapies, the UK government...

The Medicines and Healthcare Products Regulatory Agency ( MHRA) Good Manufacturing and Distribution ...

Pharmaceutical, clinical, MD, and IVD companies pursuing robustness in their software validation act...

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

Annex XVI of the MDR EU 2017/745 lists products (6 categories) without an intended medical purpose t...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently implemented a new organ...

Regulatory agencies require internal and supplier audits in the pharmaceutical and medical device in...

Pharmaceutical companies are often inspected by competent authorities to verify the manufacturer’s c...

Digital technology is transforming the way clinical trials are conducted, offering new opportunities...

Using software for your life sciences operations requires high integrity and security in the data pr...

Are you performing clinical research with medical devices? In this blog post, we provide a brief ove...

We recently published a blog post about Unique Device Identifiers (UDI). While this blog post briefl...

The European Parliament has adopted the proposal to extend the transitional period for legacy device...

The introduction of a new product into your company’s portfolio may require expanding your existing ...

In the world of life sciences, an endless stream of compliance documents is thrown around. It’s no d...

Change control management is an essential part of any quality assurance system. It enables us to mai...

Artificial intelligence (AI) and machine learning (ML) are on the rise in our society, changing the ...

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

Current regulations require written documentation for all existing products in the company; this doc...

‘Digital health‘ is on the rise. It’s a term we use more and more often. But what is digital health?...

In the post-COVID pharmaceutical landscape, electronic records and signatures are indispensable, gui...

Are you excited to bring your brand-new medical device to market? As you navigate the challenging pr...

ISO, IEC, EN ISO… References to standards can be confusing. What is the difference between these sta...

In the life science industry, Artificial Intelligence (AI) and Machine Learning (ML) validation have...

Current regulations require that manufacturing processes in the pharmaceutical industry be validated...

Although no single best practice, standard, or guideline has been specifically enforced, competent a...

GAMP 5, which stands for “Good Automated Manufacturing Processes”, is an approach that has been wide...

Any company in the pharmaceutical or medical device industry with a certified GMP, GDP or ISO 13485 ...

Custom-made medical devices are the odd ones out when it comes to the Medical Devices Regulation (EU...

In Belgium, medicine advertising is subject to specific legislation. The objective is to ensure the ...

PRRC: meaning of this new role under MDR and IVDR The Person Responsible for Regulatory Compliance o...

A job in life sciences consultancy offers plenty of challenges, variety, career opportunities, and g...

Compressed gas standards The latest draft of Annex 1, Manufacture of Sterile Medicinal Products, int...

Ever wondered why it is necessary – and sometimes absolutely essential – to perform a Data Migration...

Changes in business needs or technology are inevitable. They often lead to the retirement or “decomm...

Clinical evaluation of a medical device – defined as an ongoing collection, generation, appraisal, a...

Clinical evaluation of a medical device is central to obtaining and maintain ing market approval in ...

During the pandemic, electronic signatures gained tremendous importance for companies in heavily reg...

Before marketing a medicinal product, pharmaceutical companies must obtain a marketing authorization...

CAR-T cell therapy, a groundbreaking advancement in the pharmaceutical industry over the last 20 yea...

The new medical device regulations and the associated implementation of EUDAMED should give the gene...

New to validating computerized systems? If so, it might be difficult to get started on this type of ...

Additive manufacturing, particularly 3D printing, has attracted strong attention of the medical devi...

Dendritic cells (DCs) are crucial cells in the initiation and regulation of the adaptive immune resp...

Natural Killer cells or NK cells are large lymphocytes (white blood cells) that play a crucial role ...

In vitro diagnostic (IVD) medical devices (Manufacturers | Internal Market, Industry, Entrepreneursh...

In recent years, more and more medicinal products (MP) are used in conjunction with a medical device...

In vitro diagnostic medical devices (IVDs) have long been a part of our healthcare industry. Recentl...

Are you aware that the introduction of MDR may have affected your CE-marked medical software (MDSW)?...

One of our previous blogposts discussed medical device industry trends and innovations. Since then, ...

Artificial Intelligence is the IT word in Medical Devices nowadays when it comes to software develop...

Nowadays, digital healthcare is taking an increasingly important place in the medical world through ...

Needless to say, Brexit has had a major impact on numerous businesses. And that was no different for...

In the field of regenerative medicine, advanced therapy medicinal products (ATMPs) represent the nex...

What is a medical device? This crucial question often arises when bringing medical devices to market...

Risk management is key to promoting the safety of medical devices. So it’s with good reason that the...

T he global regenerative medicine market, including  direct-to-consumer stem cell therapy , is expec...

Industry 4.0 is currently revolutionizing the design, manufacturing and services of healthcare appli...

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

QP challenges in ATMPs Advanced Therapeutic Medicinal Products are – by definition – ‘advanced’. In ...

Today, only 18 cell and gene therapies have made it to the FDA approved therapies list. Only 14 have...

The EU Medical Device Regulation 2017/745 (MDR) and EU In Vitro Diagnostic Regulation 2017/746, (IVD...

Regulatory Affairs plays a crucial role in the pharmaceutical industry, especially during drug devel...

A short introduction and overview of the requirements In 2017, the European Commission released the ...

Do you want to distinguish starting materials used for ATMPs from those used for transplants or tran...

How to guarantee medicine quality and patient safety To explain the quality by design methodology, i...

What does an automation pyramid entail? An automation pyramid visualizes the integrated layers of te...

Hurdles to be taken As ATMPs progress towards commercialization, engineering challenges increase alo...

What is the definition of ATMP? From the website of EMA: Advanced therapy medicinal products (ATMPs)...

Advanced therapy medicinal products (ATMP) is the group of therapies in which we use cells, genes, e...

What are ATMPs and what are the challenges? According to the European Medicines Agency (EMA), ATMPs ...

First of all, let’s take a look at the manufacturing flow of vaccines. The production process consis...

Imagine guiding someone through Excel’s myriad functions in a written manual. Where to begin? With b...

Falsified medicines could seriously harm the health of patients and may even put their lives at risk...

After months of revision and many questions raised, it now appears that the time is coming to implem...

Several scientific and clinical breakthroughs of our past decade show that Advanced Therapy Medicina...

Every day, patients around the world participate in clinical trials. Their contributions are crucial...

Serialization is rapidly emerging in the pharmaceutical world. To fight counterfeit drugs, more and ...

Some encounters have big consequences. When QbD’s CEO Bart Van Acker met Antleron co-founder Jan Sch...

Over the last couple of years, the data integrity topic has received more and more attention. Recent...