Regulatory

  1. Compressed Gas Risk Assessment: A Significant Step In Your CCS 10/10/2024

    Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.

  2. Impact Of Water Activity On OSD Product Potency, Purity, And Bioavailability 11/21/2022

    Explore laser-based headspace analysis, the impact of USP<922> Water Activity on primary packing selection, and the impact of water activity on the potency, purity, and bioavailability of OSD products.

  3. Advanced CCIT Strategies For Combination Products 7/14/2026

    Gain insight into how deterministic CCIT methods support sterility assurance, product stability, and patient safety for prefilled syringes, auto-injectors, and other combination products.

  4. Annex 1 FAQs: Why Is A Good Supplier Partnership Pivotal To Meet Regulatory Expectations? 5/11/2026

    Struggling to keep pace with EU GMP Annex 1? The right supplier partnership brings critical regulatory insight your team may be missing. Learn how strategic collaboration closes compliance gaps and prepares you for future regulations.

  5. A Data-Driven Approach To Container Closure Integrity

    Gain confidence in your container closure system selection by utilizing a stepwise and data-driven approach to predicting and verifying container closure integrity.

  6. How To Evaluate The Integrity Of Intravenous (IV) Bags 7/7/2023

    Testing IV bags in compliance with Annex 1 guidelines requires a robust technology strategy to ensure product quality and patient safety. Learn how to deploy and validate technologies for IV bag CCI.

  7. Navigating Special Regulatory Pathways For Advanced Therapy Development Success 6/12/2025

    Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.

  8. Navigating GxP Compliance Challenges 10/30/2024

    Learn how to select and manage trusted software suppliers to streamline your digital transformation, mitigate risks, and ensure regulatory adherence. Watch to discover best practices and real-world examples.

  9. Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing 1/4/2021

    The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.

  10. How Crucial Is Culture Media Selection In Environmental Monitoring? 6/20/2023

    Explore culture media regulatory requirements, the impact of manufacturing guidelines and media features and specifications on environmental monitoring, and the importance of media supplier selection.