Contributing Editors

  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. 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.

  3. The Module Type Package Wants All Your Equipment To Start Talking 12/11/2025

    A forthcoming ISPE guide uses case studies to aid in the design of plug-and-play process skids with implications for every step in the manufacturing process continuum.

  4. FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs 12/11/2025

    The FDA has issued a final guidance, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.

  5. Four Reasons You Should Choose Lyophilization for Your Next Project 12/10/2025

    Lyophilization ensures product stability, extends shelf life, supports sensitive formulations, and simplifies storage and transport, making it a critical choice for modern drug development projects.

  6. Lessons In Quality From Sanofi's Plai.qa 11/24/2025

    The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.

  7. Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk 11/21/2025

    Many life science organizations collect sensitive data through outdated web forms, exposing companies to critical vulnerabilities, data breaches, regulatory penalties, and more.

  8. 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.

  9. 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.”

  10. How To Improve Sponsor–CMO Collaboration Around Digital Deviations 11/17/2025

    Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.