Contributing Editors

1. Sanofi's Digitalization Road Trip Shifts Into High Gear 9/16/2025

   The company's head of manufacturing discusses their latest investments in AI and automation, plus offers tips on how any company can start adopting advanced technology.

2. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

   Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

3. The Regulatory Imperative To Improve Environmental And Sustainability Stewardship In Biopharma 9/15/2025

   As the industry faces increasing pressure to align with environmental, social, and governance (ESG) standards, companies must evaluate how to integrate supply chain management with these initiatives to drive sustainability and mitigate risks.

4. Operating And Maintaining Pharmaceutical Gas Distribution Systems 9/12/2025

   Drug manufacturers face stringent requirements when using gas that comes into direct contact with the product. This guide discusses operation, maintenance, and monitoring of gas systems.

5. August 2025 — CDMO Opportunities And Threats Report 9/11/2025

   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.

6. The New FDA Era Of Radical Transparency And Pervasive Oversight 9/9/2025

   The first half of 2025 has been transformative for biopharmaceutical quality and regulatory affairs, with the FDA leading the charge with four significant changes. Curadian Group's David Grote discusses implications for all four.

7. Building The Biopharma Manufacturing Facility Of The Future Requires A Phased IT/OT Strategy 9/4/2025

   Your pharma or biotech company can take these actionable steps to achieve digital facility operations and successfully build your own facility of the future. 

8. FDA Report Details FY24 Inspections, Shows Big Uptick In Key Countries 8/29/2025

   The 2024 Report on the State of Pharmaceutical Quality shows the agency's efforts to normalize post-pandemic oversight under the previous administration.

9. New FDA White Paper Ties Quality To Financial Benefits 8/26/2025

   The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront.

10. Avoiding Alcohol-Induced Dose Dumping In Oral Drug Formulation 8/21/2025

    The FDA has become more vigilant about alcohol-induced dose dumping in extended-release oral dosages. Such dumping can result in anything from reduced therapeutic effects to dangerous toxicity. Let's take a closer look.