Insights On Regulatory Compliance

1. 5 Questions On Exploring Healthcare Decision-Maker Sentiments 4/14/2025

   Research presented at AMCP 2025 uses natural language processing on decision-maker feedback to predict coverage. Learn about the surprising findings and next steps in this Q&A.

2. Cleanroom Conceptual Design Paradigm: Converting Spaces For GMP Operations Part 2 6/16/2025

   Learn essential conceptual design principles for transforming alternative spaces into efficient, regulatory-aligned cleanroom environments for your critical processes.

3. Inside A Collaboration To Design Cutting Edge Modular Cleanrooms 1/31/2025

   Learn about a collaboration that has yielded advanced modular cleanrooms, integrating cutting-edge building automation, critical monitoring, and data aggregation for manufacturing intelligence.

4. The Role Of CDMOs In Supporting Generic Drug Development 7/15/2025

   Bringing complex generics to market requires deep expertise. Learn how a CDMO can help navigate regulatory, technical, and commercial challenges with end-to-end development and manufacturing support.

5. Navigating Promotional Materials Requirements In Europe 6/12/2024

   From navigating local laws to strategic planning, explore how companies can manage their promotional campaigns while adhering to strict regulatory guidelines.

6. Successful Microbial Testing And Identification 5/27/2025

   In this presentation, one of our industry-leading customers discusses how they've successfully implemented the Applied Biosystems MicroSEQ Microbial Identification System in their laboratory testing.

7. Optimizing Cleanroom Cleaning And Disinfection To Meet Annex 1 Requirements 12/27/2024

   Explore Annex 1 updates on contamination control in pharmaceutical cleanrooms, emphasizing cleaning consistency, training, advanced tools, and technologies to achieve regulatory compliance.

8. Navigating Your Holistic Approach To CCI For Biologic Drug Products 6/12/2024

   Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.

9. Resolute® BioSC Pilot: Designed For Effective And Consistent Chemical And Microbiological Cleaning 10/10/2024

   Issues related to cleaning and cleaning validation are some of the most common concerns that arise in FDA Warning Letters. Discover how to ensure you pass your cleaning validation tests.

10. Use Of Conductivity As A Tool For On-Site Residue Management 3/7/2025

    Residues from cleaning and disinfection are under increased scrutiny in cleanrooms. A new method using conductivity measurements offers a more accurate and objective way to quantify these residues.