Biosimilar Regulatory solution center

  1. Will FDA's One-Day Inspection Pilot Stand The Test Of Time? 5/19/2026

    FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.

  2. Repeating Sanofi's Ballroom Design On Two Continents 5/15/2026

    Moveable walls and a stunning number of robotics at its sites in France and Singapore, among other features, has earned Sanofi international recognition for innovation.

  3. Why Are Life Science Companies So Poorly Prepared For RIM's Future? 5/11/2026

    Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.

  4. The Stepwise Path Lilly Mapped From Paper To Digital Logbooks 4/30/2026

    Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.

  5. Minimizing Regulatory Risk For Biologics Manufacturing Changes 4/29/2026

    Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.

  6. Do Changes Signal The End Of Biosimilar Regulatory Redundancy? 4/23/2026

    First came excitement over the looming patent cliff. Then, FDA and EMA took big swings at what many have called redundant work. Combined, they make a more attractive environment for biosimilar developers.

  7. FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing 4/22/2026

    The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.

  8. U.S. Pharma Tariffs And MFN Become Law After April 2 Update 4/15/2026

    Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

  9. FDA's New Flexible CMC Framework For CGT 4/14/2026

    The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

  10. How To Implement Post-Approval Changes On A Global Level 4/14/2026

    To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.