Creating Efficiencies with Data Integrity
Over recent years relations with data and its weight have changed significantly; consequently, an assessment of Company Data Integrity is becoming one of the key metrics of corporate functionality...
Quality & Compliance
Innovation and Rapid Growth: A Double-Edged Sword
Every industry has a distinct set of obstacles to overcome, but it’s no secret that the life sciences industry encounters more speedbumps than most. Market cycles and product failures are expected,...
FDA Guidance on Gene Therapy Products: RCR Testing and Monitoring – Focus on Documenting Test Results & Post-Licensure Considerations
In January 2020, FDA issued a final guidance document on the topic of "Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture...
How to Ensure Your Workforce is GMP Compliant
As the world tries to get back to some semblance of normalcy after the coronavirus pandemic, pharmaceutical, biotech and med device companies are anticipating the day when the FDA returns to normal...
Fundamentals of Data Integrity for ATMP Development
Advanced Therapy Medicinal Products (ATMPs), or Cell and Gene Therapies (CGT), have the incredible potential to cure devastating illnesses, such as cancer, on a more personalized level. But, due to...
FDA Guidance on Gene Therapy Products: RCR Testing and Monitoring – Focus on Patient Monitoring
In July 2018, FDA issued a draft guidance document entitled "Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient...
What to Expect From an FDA Inspection, Part 2
In this continuation from “Preparing for an FDA Inspection” I will discuss what I have witnessed as a typical outline of events for FDA inspections. Prior to setting foot at the facility, the FDA...
United in Diversity: Six Tips for European Batch Release
Europe consists of 44 countries, and 21 supranational organizations and within the EU alone there are 24 official languages. So, how do you navigate the differences across Europe in the EU? And more...
Medical Monitoring: Learning from the Past & Looking Ahead
Reflecting on the 1937 Elixir of Sulfanilamide incident we can clearly appreciate the importance of clinical trials and monitoring patient safety today. For those that may not know, Sulfanilamide was...
Quality & Compliance
Deep Dive: FDA Guidance on Gene Therapy Products: RCR Testing and Monitoring
In January 2020, FDA published a guidance document entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient...
Preparing for an FDA Inspection, Part 1
The ultimate goal of the U.S. Food and Drug Administration is to protect the public welfare and protect consumers from unsafe products. Regulatory investigators are responsible for enforcing...
Quality & Compliance
Tips for Effective Commercialization in Europe From A Quality Perspective
The implementation of a robust Quality Management System (QMS) is a key success factor for clinical development with the goal of reaching marketing authorization. As important as your QMS is during...
Enhancing CRO Capabilities with Independent Physician Services
The involvement of Medical Monitoring (MM) and Data Safety Monitoring Boards (DSMB) in trials has been somewhat unknown to individuals outside of clinical circles. That is, until media attention...
Quality & Compliance
Post-COVID Challenges with Investigation Backlog: Are You Ready for the Inevitable?
In early 2020, while COVID-19 was wreaking havoc on public health and safety, the FDA took the unprecedented step of postponing domestic and foreign inspections. The FDA’s risk-based inspection...
Quality & Compliance
FDA Guidance on Gene Therapy Products: RCR Testing and Monitoring
Gene therapy holds the promise of curing severe genetic diseases at the genetic level rather than merely treating the symptoms as is accomplished using conventional small-molecule drug therapies. In...
Quality & Compliance
Understanding Responsible Person and Wholesaler Dealers Authorization
Wholesaling is a key factor for drug manufactures and Marketing Authorization Holders (MAH) to ensure supply of pharmaceutical products to their customers at pharmacies and hospitals. Wholesaling of...