Insights On Regulatory Compliance

  1. Leachables Method Development, Validation And Relevant ICH References 5/16/2025

    It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

  2. What Is The Position Of Regulatory Authorities On PUPSIT? 5/2/2025

    PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.

  3. How Compliance-Driven CDMOs Win Sponsor Contracts 8/6/2025

    Discover how evolving global regulations are reshaping CDMO strategy. and how digital infrastructure helps manufacturers stay audit-ready, build sponsor trust, and turn compliance into an advantage.

  4. Winning Strategies For Oral Dosage Form Development And Manufacturing 10/7/2024

    Failure to identify a compound’s red flags early in development often manifests as program delays or failures. Discover how to avoid these setbacks through complete molecular characterization.

  5. A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration And Single-Use Systems 10/3/2024

    One way to address risk related to product quality is by implementing a Question-Based Review approach. Read on to learn about this approach and its advantages.

  6. Biopharmaceutical Manufacturing Conference: Embracing Technology And Innovation 11/6/2024

    Industry leaders gathered at the PDA Ireland Chapter event to discuss how innovation and technology are transforming biopharmaceutical manufacturing, addressing challenges, and driving efficiency.

  7. Challenges In Developing Medical Devices From Animal-Based Biomaterials In China 11/11/2024

    Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

  8. Lessons Learned From Implementing The FDA's CSA Guidance: Summarizing 8/20/2024

    Companies adopting CSA methodologies are not achieving the efficiencies they expected from the new guidance. This series identifies issues found during CSA implementations and how to avoid them.

  9. A Shift Towards Biofluorescent Particle Counters In Manufacturing 5/12/2025

    Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.

  10. Reducing Risk, Decreasing Timelines, And Optimizing Outcomes 8/7/2025

    Explore the challenges of cell line development (CLD) in biologics commercialization and discover how integrated solutions can streamline your strategy, reduce risks, and optimize outcomes.