Contributing Editors

1. 2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For 1/5/2026

   2026 is shaping up to be a year in which operational discipline, strategic alignment, and regulatory preparedness will differentiate high-performing sponsors from those facing avoidable delays.

2. A Deeper Look At Pharma's Structural Supply Chain Vulnerability 12/31/2025

   Fixing limited capacity in pharmaceutical CMC development starts with understanding a complex web of root causes.

3. Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis 12/17/2025

   Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

4. November 2025 — CDMO Opportunities And Threats Report 12/16/2025

   Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.