Contributing Editors

  1. Implementing AI Solutions In GMP While Managing Risk 8/28/2026

    When using artificial intelligence in GMP settings, risk management extends far beyond  validation. This discussion explores moving AI solutions out of the pilot phase.

  2. Implementing And Optimizing Your eQMS 8/25/2026

    This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.

  3. Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing 8/25/2026

    Many small molecule products no longer require massive production. Instead, flexible capacity is needed that can economically produce smaller commercial volumes while maintaining quality and compliance.

  4. CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers 8/20/2026

    Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.

  5. The Complex Anatomy Of An ADC Tech Transfer 8/20/2026

    Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.

  6. A Much-Improved Approach For Understanding And Managing Safety Risks 8/18/2026

    Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

  7. CSV Assumes The AI System Sits Still — It Doesn't. 8/17/2026

    The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.

  8. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

    Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

  9. June 2026 — CDMO Opportunities And Threats Report 7/30/2026

    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.

  10. Reshoring Pressure Meets Manufacturing Reality 7/27/2026

    U.S. pharma can't reshore what domestic capacity can't absorb. Senior leaders from Takeda, Biogen, Eli Lilly, and others reveal why tariff pressure is colliding with a sterile fill-finish shortage, workforce gaps, and ADC capacity bottlenecks.