Clinical Research Solutions
Scientific Data Works: Using Science to Navigate the Global Regulatory Maze
You’re developing an FDA- and/or EMA-regulated drug, biologic, or medical device. Throughout the drug development process, your goal is to get to the next regulatory milestone in the most expeditious...
Clinical Research Solutions
3 Basic Data Integrity Principles to Protect Value and Drive Success for Cell and Gene Therapy/ATMP Development
Cell and Gene Therapy (CGT)/Advanced Therapy Medicinal Products (ATMPs) have the incredible potential to cure devastating illnesses, such as cancer, on a more personalized level. But, due to the...
Quality & Compliance
Pre-Approval Inspection (PAI): What it is and How to Prepare
What is a Pre-Approval Inspection (PAI)? A pre-approval inspection (PAI) is performed to provide the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug...
Quality & Compliance
How Data Integrity Supports a Smooth Transition to Pharma 4.0
The coming pharmaceutical industrial revolution, Pharma 4.0, is an implementation of new systems into the various manufacturing processes leading to an automated production. Introduction of these...
Clinical Research Solutions
FDA Guidance for Non-COVID-19 Related Clinical Trials During the Pandemic
In March 2020, the FDA published a guidance entitled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency - Guidance for Industry, Investigators, and Institutional...
Clinical Research Solutions
How Coronavirus Brings Forward New Technologies: The Future of Remote CSV
Is remote Computerized Systems Validation the future standard? Crises are fertile ground for inspiration and creativity resulting in practical new ideas for the near future, as is the case during the...
Clinical Research Solutions
FDA Emergency Use Authorizations 101: COVID-19 Medical Devices
Everything You Need to Know About Emergency Use Authorizations for Medical Devices to Test and Diagnose COVID-19 In early February, the Secretary of HHS declared that the circumstances presented from...
Clinical Research Solutions
FDA: CGMP Consultant Recommendation
Reflecting on my interactions with FDA I have come to understand that inspectors do not routinely offer recommendations to firms, when an inspector does provide an opinion it is often prefaced with a...
Clinical Research Solutions
FDA's Top 483 Observations for 2017: A Reflection of Industry's Compliance
At the beginning of each federal fiscal year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. I find that reviewing these metrics provides a valuable...
Clinical Research Solutions
CPV versus APR, What’s the Difference?
As an outcome of the 2011 Food and Drug Administration Process Validation Guidance, there has been ever increasing interest in the pharmaceutical industry to establish formal Continued Process...