Insights On Regulatory Compliance

  1. Minimizing Volume Requirements, Turnaround Time For Compendial Testing 10/30/2025

    Effectively applying compendial testing to cell and gene therapy products requires strategic test ordering and specialized micro-equipment to manage limited volume and accelerate turnaround time.

  2. The Impact Of The FDA's New CSA Draft Guideline 2/24/2025

    Ensure product quality and patient safety by examining the FDA's draft guideline on Computer Software Assurance that emphasizes a risk-based approach to streamline software validation.

  3. Viral Gene Therapy: Reducing Costs To Improve Patient Access 7/23/2025

    Gene therapy is revolutionizing medicine with its potential to cure genetic disorders. As approvals rise, so do concerns about accessibility, with million-dollar price tags limiting patient access.

  4. Overcoming Challenges In Ophthalmic Formulations 8/27/2025

    Discover key strategies for overcoming formulation challenges in ophthalmic drug development and learn how selecting the right excipients supports quality, compliance, and safety.

  5. A Compact, Flexible, And Easy To Use Benchtop Mixer 11/4/2025

    Compact, flexible, and easy to use, this benchtop mixer supports volumes from 100 mL to 10 L with integrated sensing options and GxP-compatible software, ideal for efficient, reproducible mixing.

  6. Forge Boosts Efficiency And Compliance During External Collaboration 1/21/2026

    Streamlined collaboration and unified quality systems are helping CDMOs cut review times. Discover how connected workflows improve compliance and efficiency for faster delivery of life-changing treatments.

  7. Sustainable Analytical Labs: Software For Greener Chromatography 6/18/2026

    Chromatography's environmental footprint is often overlooked. Applying green chemistry principles reduces solvent use and waste, unlocking sustainable workflows without losing performance.

  8. 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.

  9. Key Considerations For Rapid Microbial Methods For Mycoplasma Detection 5/29/2025

    Learn the importance of demonstrating product specific suitability, defining representative sample, consistent sampling protocols, accommodating volume and turnaround time constraints, and the need to establish equivalence.

  10. Driving Sustainability In Bioprocessing With Biobased Single-Use Solutions 11/7/2025

    Discover how biobased materials in bioprocessing enable measurable carbon emission reductions. Learn practical strategies to meet decarbonization goals and adopt greener, operationally sound practices.