Biosimilar Regulatory solution center

1. What 2025 FDA Warning Letters Tell Us About GMP Compliance 12/15/2025

   This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

2. Product Carbon Footprints: The Next Frontier In Sustainable Innovation 12/12/2025

   Product Carbon Footprints reveal true lifecycle emissions, enabling collaboration, innovation, and informed decisions. Learn why moving from estimates to evidence is essential for reducing Scope 3 impact.

3. Unpacking The EU's Mutual Recognition Agreements For Pharma 12/12/2025

   MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

4. Speed Meets Precision With Process Development Services 11/24/2025

   Explore strategies to accelerate biosimilar development that help manufacturers reduce timelines, optimize workflows, and meet regulatory standards while delivering cost-effective therapies.

5. Here's What You Need To Know About The Access Consortium Pathway 11/20/2025

   Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.

6. FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK 11/19/2025

   The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.

7. Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations 11/18/2025

   A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

8. Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development 11/17/2025

   The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.

9. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

   The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

10. Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms 10/22/2025

    The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.