Insights On Regulatory Compliance

  1. Contamination Control Strategies For Gene Therapy Manufacturing 7/23/2025

    Gene therapy manufacturing demands a careful balance between contamination control and efficiency. A strategic approach to “critical aseptic” designation is essential to meet evolving regulatory challenges.

  2. 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.

  3. Sample Preparation Automation For Immunosuppressant Drug Analysis 10/10/2025

    Discover how automated sample prep for immunosuppressant drug analysis improves accuracy, reduces contamination, and streamlines LC-MS/MS workflows.

  4. How Generative AI Streamlines GxP Compliance In Life Sciences 9/20/2024

    Generative AI is reaching a critical juncture in the life sciences industry. Learn how it is changing the game for GxP Compliance and enabling organizations to improve operational efficiency.

  5. Sniffing Out Solutions In The Nasal Drug Delivery Revolution 10/7/2025

    As research continues to advance, nasal drug delivery stands at the intersection of innovation and practicality — offering a unique opportunity to expand therapeutic reach while rethinking how medicines are administered and experienced.

  6. Just Press Start To Begin Manually Counting Particles In Your Cleanroom 5/6/2024

    With the press of a button, you can immediately start taking particle counts in your cleanroom using a portable particle counter for easy cleanroom monitoring.

  7. The Hidden Costs Of FDA Recalls: A QMS Guide To Prevention 1/28/2025

    Did you know that FDA recalls have increased 115% since 2018? Learn more on how to avoid common recall mistakes and effective recovery strategies for your company today.

  8. Optimizing Aseptic Processing With Isolator Technology 9/29/2025

    Discover how pharmaceutical isolators optimize operations, achieve higher sterility assurance, and meet stringent regulatory requirements. Learn about design principles, validation, and VHP cycles.

  9. 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.

  10. The Ex-Regulator's View On Small Surface Contamination Control 2/26/2025

    Effective small surface disinfection in cleanrooms requires adherence to detailed procedures and best practices. ​Learn about the critical steps, techniques, and validation needed to ensure product safety.