Insights On Regulatory Compliance

  1. Nitrosamines - New Requirements To Evaluate Contamination Risks 12/23/2024

    Explore nitrosamine contamination, regulatory actions, and new evaluation requirements, featuring expert insights from Dr. Ulrich Reichert on prevention and risk assessment strategies.

  2. Visual Inspection Of Advanced Therapy Medicinal Products 9/2/2025

    Discover how expert database systems for inspection defect management and control help cell and gene therapies meet the requirements of USP-790 to assure they are essentially free from particulate matter.

  3. Why Cleanroom Wipe Fabrics Matter 6/16/2025

    Discover the key fabrics used in cleanroom wipes and how they impact performance, as well as explore substrates, manufacturing methods, and essential attributes to help you choose the right wipe.

  4. Does My Cleanroom Facility Need A Residue Removal Step? 3/28/2024

    Explore the challenges presented by the residues left behind by disinfectant solutions in cleanrooms as well as effective strategies for their management.

  5. Merck Process Transfer And Scale-Up Of Batch Protein A 6/30/2025

    Explore cost-saving innovations in purification using a system that achieves consistent product quality and yield while significantly reducing resin use and enhancing large-scale efficiency.

  6. Modernizing Compendial SEC Methods For Biotherapeutics 4/16/2024

    Explore the advantages of a bio-inert HPLC system through the migration and modernization of a compendial SEC method outlined in the United States Pharmacopeia (USP) General Chapter <129>.

  7. Client Story: Efficiency Enabling CSV At Scale 7/1/2025

    Discover how Fujirebio Diagnostics digitized their global CSV processes to achieve a 53% time reduction in CAPA projects and streamline validation with remarkable efficiency gains.

  8. Strategies For QA Professionals In Life Sciences 7/14/2025

    Explore challenges QA professionals face in document reviews and expert strategies to boost accuracy, streamline workflows, and ensure compliance with evolving regulatory standards.

  9. Navigating The Regulatory Space To Biosimilar Approval 9/1/2025

    The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.

  10. Vaccine Fill Line Operations 11/24/2025

    Learn how adopting a harmonized, risk-based validation strategy across global sites can reduce operational readiness timelines and drive improvements in equipment effectiveness and regulatory compliance