Clinical Supply Regulatory Articles

1. FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies 5/24/2024

   This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29.

2. What Sponsors Must Know About Digital Systems And AI Compliance 7/17/2025

   Consultant Jessica Cordes provides an update on proposed changes to GMP guidance that affect trial conduct, including documentation, computerized systems, and the use of AI.

3. Vendor/Supplier Management To Maintain A Drug's Safety Profile In End-To-End Supply Chain Planning 8/17/2023

   FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management, and we expect regulators to issue firmer guidance sooner rather than later. Don't let your pharma/biotech fall short.

4. Managing Supply Chain Risk In Scale-Up And Multisite Trials 1/23/2026

   Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.

5. Navigating Brazil's Medical Device Clinical Trial Import Process 1/27/2026

   When medtech sponsors plan clinical trials in Brazil, many overlook a critical bottleneck that can delay trial launches by months: the process of importing clinical trial materials.

6. The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials 5/12/2025

   Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

7. Good Distribution Practice Is Evolving — Here's How 5/15/2025

   Managing a global supply chain for increasingly complex biologic drugs takes special attention and expertise. Explore the key drivers of a modern logistics management plan.

8. Warning To U.S.-Based CDMOs: Don't Get Complacent 9/9/2024

   How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO  of his eponymous consulting company. His response did not disappoint.

9. Managing Risk And Resilience In Clinical Trial Supply And Operations 2/12/2026

   Clinical leaders are shifting from reactive fixes to deliberate governance and early decision-making to sustain trial continuity under persistent operational uncertainty.

10. What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma? 10/9/2025

    Deciding what is good enough to get started can support the mindset of building something without sacrificing quality, functionality, or safety.