Insights On Regulatory Compliance

  1. The Evolution Of EAM/CMMS In Pharma Manufacturing 8/8/2025

    Explore pharma’s shift from paper-based maintenance to modern EAM/CMMS that shows how digital tools boost compliance, reduce downtime, and improve data accuracy and productivity.

  2. EU GMP-Annex 1: Changes, Challenges, And Ready-To-Use Sterile Packaging 8/27/2024

    Leveraging a pre-sterilized containment solution that meets the requirements of Annex 1 and outsources non-core activities can help prevent contamination and reduce the effort and liability of the CCS.

  3. Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs 8/27/2024

    Ready-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. See how they can minimize complexities and better align with the stringent demands of modern manufacturing.

  4. Development Of An Effective LC-MS/MS Cleaning Validation Method 7/17/2025

    Gain insight into a robust LC-MS/MS method for quantifying therapeutic peptides that supports contamination control and cleaning validation to ensure product safety and integrity.

  5. Drive Innovation With Validation 4.0 7/1/2025

    Discover how Validation 4.0 can revolutionize your organization by boosting innovation, efficiency, and compliance with strategies that overcome challenges and stay ahead of evolving regulations.

  6. A New Framework For Identifying Nitrosamine Risks And Derisking Products 6/18/2024

    Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

  7. GMP Calibration Management 8/8/2025

    Learn why generic EAM systems fall short in regulated industries and how purpose-built solutions ensure compliance, efficiency, and audit readiness.

  8. Annex 21 – Are We On Track And Is There An Impact? 5/6/2024

    What does Annex 21 entail? What makes the process of meeting the requirements so complex and time-consuming? And has Annex 21 inadvertently created additional barriers to supply?

  9. How To Get Ready For 21 CFR Part 820/ISO 13485 Harmonization 9/20/2024

    Explore the key aspects of the harmonization between 21 CFR Part 820 and ISO13485 and guidance regarding how to ensure compliance with the new Quality Management System Regulation (QMSR) standards.

  10. Accelerated Tox Offerings: A Recipe For Streamlining IND Applications 4/22/2025

    Accelerating the timeline to tox material can significantly enhance the drug development process, enabling faster IND submissions and providing crucial time savings for toxicology studies.