Featured Articles

  1. Designing Robust Studies To Meet Auto-Injector Performance Requirements 10/30/2025

    Learn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of applications ranging from emergency use to treating chronic conditions.

  2. Establishing And Safeguarding Shelf Life In Combination Products 10/27/2025

    Establishing combination product shelf life requires aligning stability. Holistic, data-driven stability studies ensure product function, safety, and label claims through the entire supply chain.

  3. A Pathway For Regulatory Success For Devices In Combination Products 10/27/2025

    Ready to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and proactively manage evolving regulations to achieve a successful path to market.

  4. FAQs On The Revised EU GMP Annex 1: Volume 6 9/21/2025

    The revised EU GMP Annex 1 prioritizes a CCS. Learn how to holistically manage microbial, particulate, chemical, and cross-contamination risks to ensure product sterility and patient safety.

  5. Taking A Best Practice Approach To Contamination Control  9/21/2025

    Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, data analytics, and continuous improvement for a zero-defect mindset.

  6. Laying Supply Chain Foundations That Bring Confidence To Compliance 9/21/2025

    Compliance with EU GMP Annex 1 requires a strategic CCS. Learn how a framework based on people, communication, process, and continuous improvement enables systematic, long-term compliance.

  7. FAQs On The Revised EU GMP Annex 1: Volume 3 9/21/2025

    The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.

  8. Vial Adapter Transfer Device Compatibility With Cell Therapies 7/25/2025

    Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.

  9. Safely Navigating The Transition From MDD To MDR 7/25/2025

    If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

  10. De-Risking The Transition From Vial To Drug-Device Combination Product 7/25/2025

    When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.