Blogs

Apr 22 2026

NAMs & Regulatory Acceptance – Part 3/3: Validation, Qualification and Fit‑for‑Purpose

Apr 22 2026

NAMs & Regulatory Acceptance – Part 1/3: Why Regulators Are Accelerating a Scientific Shift

Apr 22 2026

NAMs & Regulatory Acceptance – Part 2/3: How EMA and FDA Are Embracing NAMs

Feb 13 2026

Understanding Controlled Correspondence: A Key Tool in Generic Drug Development

In the world of generic drug development, clarity is everything. Sponsors depend on timely, accurate guidance from the U.S. Food and Drug Administration (FDA) to make informed technical and regulatory decisions that shape the success of an Abbreviated New Drug Application (ANDA). One of the most important mechanisms for obtaining this clarity is Controlled Correspondence […]

• FDA
• Regulatory strategy

Oct 15 2025

Unlocking the Nordics: Pharma Strategies That Deliver Impact

• Market Access

Sep 11 2025

Clinical Trials Series: Part 4 – Data Integrity in the EU: What sponsors must know to stay compliant

• Clinical Trials

Aug 08 2025

Clinical Trials Series: Part 3 – Design with the Mitigating Risk in Your First EU Trial: Operational, Regulatory, and Strategic Thoughts

• Clinical Trials

Aug 06 2025

China’s IP Protection Reform on Patent Term Extension (PTE): Impact on Drug Development and Regulatory Strategies

• China
• NMPA
• Regulatory strategy

Jul 10 2025

Clinical Trials Series: Part 2 – Design with the Patient in Mind: Building a Patient-Centric Protocol

• Clinical Trials
• Patient Engagement

Jul 07 2025

What Defines a Healthy Microbiome?

Published on: Jul 7th, 2025 Introduction A “healthy” microbiome plays a key role in maintaining human health by supporting digestion, skin balance, reproductive function, immune response, and overall physiological balance. Yet, defining what exactly constitutes a healthy microbiome remains a major scientific challenge due to individual variability, environmental influences, and methodological inconsistencies. This article explores […]

• Microbiome

Jun 27 2025

Navigating the Future of Pharma Manufacturing with FDA’s Advanced Manufacturing Technologies Designation Program

• CMC
• FDA

Jun 23 2025

Clinical Trials Series: Part 1 – First Steps into Europe: Key Considerations for Your First EU Clinical Trial

• Clinical Trials
• EMA

May 21 2025

ICH E6(R3) and the Future of Clinical Trials: A Guide for Biotech Sponsors

• Clinical Trials

Mar 28 2025

How to Ensure Safety and Efficacy in Medical Device Vigilance via Patient Engagement

• Medical device
• Patient Engagement
• Vigilance

Mar 25 2025

Understanding Microbiome Testing Kits: What They Are and How They Are Used

• Microbiome
• Regulatory strategy

Feb 25 2025

The Nordic Opportunity: Turning Real-World Data into a Rare Disease Research Powerhouse

Over the past decade, rare diseases have gone from a niche to a major focus in pharma, thanks to regulatory incentives and advances in precision medicine. Biotech and big pharma have figured out that despite small patient populations, there are significant unmet medical needs, and these drugs provide sound business opportunities. As of February 2025, […]

• Market Access
• Orphan & Rare Disease

Feb 24 2025

Patient Centricity: The Foundation of Modern Healthcare Through Meaningful Engagement 

• Regulatory strategy

Feb 05 2025

Key Insights from FDA’s Draft Guidance on FAQs for CGT: Quality and Regulatory Interactions

• Cell & Gene Therapy
• CMC
• FDA

Nov 20 2024

The SoHO Regulation: A Step Forward in European Health and Safety

• CMC

Oct 14 2024

New policy opens China biotechnology sector

• China
• Regulatory strategy

Oct 09 2024

Unlocking the potential benefits of Live Biotherapeutic Products (LBPs) for the treatment of bacterial vaginosis (BV)

• Microbiome

Jun 19 2024

Navigating the New FDA Draft Guidance on Platform Technologies: An Overview for Life Sciences Companies

• FDA

Jun 17 2024

De-risk Clinical Trials by Starting with Patient Insights and their Integration

• Clinical Trials

Jun 14 2024

Overcoming the key hurdles in the development of Phage Medicinal Products

• Microbiome
• Regulatory strategy

May 30 2024

Incorporating patients’ voices in the drug development process

• FDA

May 30 2024

An advocate of collaboration : Flora Giorgio interview

May 30 2024

Driving the healthcare regulatory system into the future

• Combination Products
• Medical device

May 30 2024

TOPRA/RAPS workshop on alignment of global combination products

• Combination Products
• Medical device

May 30 2024

Addressing the impact of the EU medical devices regulation on combination products

• Medical device
• Regulatory strategy

Apr 30 2024

Accelerating Innovation: FDA Expedited Programs 101

• FDA
• Regulatory strategy

Apr 22 2024

Achieve Success for Your First US Product Application – Pathway to IND

• FDA
• Regulatory strategy

Apr 17 2024

A deep dive into the regulatory framework for Phage Medicinal Products

• Microbiome
• Regulatory strategy

Apr 02 2024

Sponsors of Clinical Trials in the EU/EEA – Call for Action!

• Clinical Studies
• Clinical Trials
• EMA
• Regulatory strategy

Mar 15 2024

Digital Health Series – Part 5: Key Challenges for Software and AI as a Medical Device

• Digital Health
• Medical device
• Regulatory strategy

Feb 27 2024

Digital Health Series – Part 4: Software as a Medical Device Regulated by the UK

• brexit
• Digital Health
• Medical device
• Regulatory strategy

Feb 06 2024

The International Recognition Procedure – The United Kingdom’s new route for accelerated marketing authorization

• brexit
• Regulatory strategy

Jan 12 2024

Best ePRO practices – A patient centric approach

• Clinical Trials

Jan 11 2024

Q&A regarding common concerns of China’s NMPA (National Medical Products Administration)

• China
• Regulatory strategy

Nov 01 2023

Navigating the FDA Draft Guidance Document “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products”

• Cell & Gene Therapy
• FDA

Oct 31 2023

Digital Health Series – Part 3: Software as a Medical Device Regulated by the EU

• Digital Health
• Medical device
• Regulatory strategy

Oct 20 2023

The regulatory challenge for determining status between medical devices and cosmetic products with borderline claims – Part 2

• Medical device
• Regulatory strategy

Sep 28 2023

FDA Meeting Series: How, When and What – INTERACT Meetings

• FDA

Sep 06 2023

The regulatory challenge for determining status between medical devices and cosmetic products with borderline claims – Part 1

• Medical device
• Regulatory strategy

May 24 2023

Digital Health Series – Part 2: Software as a Medical Device Regulated by the US FDA

• Digital Health
• Medical device
• Regulatory strategy

Apr 27 2023

Selection of a Notified Body for Medical Device Development

• Medical device
• Notified Body
• Quality Assurance
• Regulatory strategy

Apr 21 2023

Digital Health Series – Part 1: Defining Software as a Medical Device

• Digital Health
• Medical device
• Quality Assurance
• Regulatory strategy

Apr 05 2023

Importance of Quality Management Review for Medical Devices 

• Medical device
• Quality Assurance
• Regulatory strategy

Jan 20 2023

How can you take advantage of China’s accelerated regulatory pathways for your product development?

• China
• NMPA
• Regulatory strategy

Dec 16 2022

The EU Regulatory Framework for Microbiota Transplants: An Industry Perspective

• CMC
• Microbiome
• Regulatory strategy

Nov 17 2022

Key Points in the CTR Transition of Clinical Trials

• Clinical Studies
• Clinical Trials
• EMA
• Regulatory strategy

Sep 06 2022

Critical Materials considerations for Cell and Gene therapy product development – Part 2

• CGT
• EMA

Aug 30 2022

Critical Materials considerations for Cell and Gene therapy product development – Part 1

• CGT
• EMA

Aug 25 2022

FDA Meeting Series: How, When and What – EOP Meetings

• FDA

Aug 16 2022

FDA Meeting Series: How, When and What – pre-IND Meetings

• FDA

Jul 21 2022

FDA Meeting Series: How, When and What – General Introduction

• FDA

Jun 06 2022

Cell banks characterization expectation for microbiome therapeutical products

• CMC

Nov 08 2021

FDA Advisory Committee Meeting on Toxicity Risks of AAV Vector-Based Gene Therapy Products: a CMC Perspective

• CMC
• FDA

Sep 29 2021

Non-traditional US Regulatory Programs for Drug and Medical Device Development

Sep 29 2021

Social Security Finance Bill 2021 in France: Reform on early access to health technologies What to expect?

• Market Access

Sep 24 2021

IVD Directive to IVD Regulation (EU 2017/746) Transition – 8 Months Remaining

• IVD

Aug 04 2021

COVID-19 – THE LEARNINGS AND LONG-TERM IMPACT IN CLINICAL STUDY MANAGEMENT IN THE EU/UK

• Clinical Trials

Mar 09 2021

2021 Advancing Regulatory Science at FDA: What are the focus areas

• FDA

Feb 15 2021

The implementation of the Clinical Trial Regulation (Regulation (EU) No 536/2014): where do we stand?

• Clinical Trials

Nov 05 2020

Summary of FDA Advisory Committee on COVID-19 Vaccines (Oct 22)

• FDA

Oct 19 2020

What are the Need-to-Know incentives associated with an Orphan Drug Designation (ODD)?

• Orphan & Rare Disease

Sep 17 2020

New FDA Guidance on Multiple Function Device Products & Its Impact on Software as A Medical Device

• Digital Health
• Medical Devices

Jul 07 2020

New Guidance on Clinical Evaluation of Medical Device Software

• Digital Health
• Medical Devices

Jul 03 2020

Advice on Non-clinical and Clinical Development for ATMPs from an Ex-CAT member

• CMC
• EMA

Mar 31 2020

Expectations from Regulatory Agencies on Nitrosamine Impurities

• CMC
• EMA

Mar 18 2020

How to Successfully Manage The Challenges of Developing an ATMP

• Cell & Gene Therapy

Nov 29 2019

The Microbiome Journey: Development of a Drug Product

• Microbiome
• Regulatory strategy

Nov 29 2019

What should you know about the Trial Master File: a refresher

• Clinical Trials

Nov 29 2019

Are you making the most of the incentives and benefits that are available to support small businesses?

• EMA

Nov 29 2019

The Microbiome Journey: Development of a Food Product with Health Claims

• Microbiome
• Regulatory strategy

Nov 28 2019

Microbiome health products: drugs or foods?

• Microbiome
• Regulatory strategy

Nov 28 2019

How to Choose a Medical Writer?

• Publishing

Nov 28 2019

New regulations for IVD Manufacturers when developing new devices

• Medical device
• Regulatory strategy

Nov 28 2019

Medical Writers brace themselves for new EU regulations

• Publishing

Nov 28 2019

Do I need to comply with Policy 70 ?

• Publishing

Nov 28 2019

Update on The Redistribution of UK’s portfolio of centrally authorised products

• Market Access

Nov 28 2019

EU Downplays likelihood of UK staying in EMA after Brexit

• EMA

Nov 28 2019

Brexit update: EMA & Join Trade Association Meeting on 23rd March 2018

• EMA

Nov 28 2019

Key figures and dates of the Impact of Brexit for Pharmaceuticals

• EMA