Insights On Regulatory Compliance

  1. Shifting The Approach: 4 Tactics For ICH E6(R3) Implementation 4/30/2024

    In addition to codifying some best practices, R3 recommends that sponsors adopt an approach to identifying and managing areas of risk to mitigate potential issues and enhance overall success.

  2. 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.

  3. Key Takeaways From The ISPE Aseptic Processing Seminar 4/14/2025

    How is the pharmaceutical industry increasing aseptic processing safety? An ISPE event showcased innovations like robotics and improved risk management, aligning with recent regulatory guidance.

  4. A Blueprint For Avoiding FDA Recalls 10/9/2024

    Avoid FDA recalls and safeguard your life sciences business. Learn how QMS and EBR/eDHR solutions can prevent costly product recalls and ensure compliance with FDA regulations.

  5. Why Should CDMOs Adhere To The New CDER's Rating System? 5/16/2024

    Delve into the benefits of the FDA's Quality Management Maturity (QMM) program, the rating system’s evaluation criteria, challenges, and steps to overcome these hurdles and achieve excellence.

  6. The Importance Of 503B Facilities In Drug Manufacturing Today 10/5/2023

    Here, we share one of the best ways to ensure sterility in aseptic compounding operations and how 503A and 503B pharmacies can achieve the adaptability they need to scale their operation.

  7. How To Establish Effective, Scalable Drug Safety Ops Across Vendors 7/9/2024

    Numerous factors impact a drug safety program, but proper management of three key elements drives success while creating a scalable drug safety model.

  8. Advancing Cell Therapy Manufacturing: Rapid Sterility Testing 5/7/2024

    The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.

  9. Solving The Silicone Challenge In Pre-Fillable Syringes 8/27/2024

    Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

  10. Exploring Payer Coverage Of Anti-Obesity Medications 4/14/2025

    Understanding payer strategies for anti-obesity drugs is crucial. A recent study investigated commercial formulary trends, confirming cost as a major barrier despite positive patient outcomes.