Biosimilar Regulatory solution center

  1. Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation 6/8/2026

    Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

  2. A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis 6/5/2026

    This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

  3. AI Has Arrived In Biotech CMC Amid Patchwork Governance 6/3/2026

    AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.

  4. What Reliance, Annex 1, And AI Mean For The Future Of GMP 5/29/2026

    EMA’s Brendan Cuddy explains how regulators are adapting oversight to global supply chains, new technologies, and growing operational complexity.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.