Insights On Regulatory Compliance

  1. How To Implement Three Cleaning Best Practices For Your Cleanroom 3/28/2024

    Learn about the three cleaning best practices that will make a difference in your cleanroom, the importance of each step, and how to implement these strategies.

  2. Essential Insights Into Pharmaceutical Product Release, Part 1 Of 2 12/27/2024

    Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical, comprehensive process essential for FDA approval and patient safety.

  3. 5 Steps To Completing A Successful Root Cause Analysis 5/30/2025

    Discover how Root Cause Analysis transforms manufacturing by addressing underlying issues, improving quality, and preventing future failures, which empowers teams to move from reactive fixes to strategic solutions.

  4. Testing Cell-Based Immunotherapeutics For Microbial Contaminants 10/23/2023

    In this study, two different immune cell preparations were evaluated for their compatibility with the Milliflex® Rapid System to establish a USP and EP compliant method for rapid sterility testing.

  5. A Mobile BSL-2 cGMP Cleanroom Delivered In Less Than 3 Weeks 6/6/2024

    A mobile cleanroom facility was needed for manufacturing a new monoclonal antibody product for phase 1 clinical trials. The facility had to have the ability to be repurposed for additional applications.

  6. How To Navigate The EU HTA Regulation For Better Market Access 10/21/2024

    The EU's new Health Technology Assessment Regulation poses challenges and opportunities for the biopharma industry, making manufacturers adapt to unpredictable PICOs and prioritize scenario planning.

  7. Five Steps To Implementing CSA 12/17/2024

    Explore how the FDA’s CSA guidance simplifies computerized systems validation by emphasizing risk-based approaches, reducing documentation burdens, accelerating testing, and enhancing compliance.

  8. Understanding Biosafety Levels 5/20/2024

    Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.

  9. What Do You Need To Do To Qualify A Single-Use Assembly? 8/28/2024

    Learn about the implementation of single-use technologies, single-use user requirement specifications, and best practices for single-use qualification, including quality and regulatory documentation.

  10. Validating Pharma 4.0 For Smart Manufacturing 1/24/2025

    Explore the digital evolution of manufacturing control and management, the building blocks of Pharma 4.0, and how the life sciences industry can realize the full potential of Pharma 4.0.