Featured Insights

  1. How Will Medical Devices Be Affected In The Era Of EU HTA? 3/18/2025

    The EU Health Technology Assessment Regulation (HTAR) mandates Joint Clinical Assessments (JCAs) for high-risk medical devices and medicines, guiding manufacturers in clinical study requirements and regulatory compliance.

  2. Achieving Best Outcomes With TMF Document Processing 3/18/2025

    TMF document processing requires a delicate balancing act. Sponsors strive for accuracy and completeness, but timeliness is crucial. How can teams achieve all three? Here are some practical strategies.

  3. The Important Role Of The Study Owner In Guiding The TMF 3/18/2025

    Learn about the critical role that a study owner plays in maintaining Trial Master File (TMF) oversight, ensuring compliance, and driving collaboration across clinical study teams.

  4. Understanding The UK's International Recognition Procedure 3/18/2025

    The UK's International Recognition Procedure (IRP) streamlines market access for medicines. Learn how its targeted assessments foster quicker approvals and innovation.

  5. What The Inspectors Want: A Guide To TMF Inspection-Readiness 3/18/2025

    Regulatory authorities expect sponsors to maintain proper TMF oversight. This article outlines strategies for inspection readiness, risk-based reviews, access control, and best practices for successful compliance.

  6. Three Key Takeaways From The PDA Annex 1 Workshop 3/17/2025

    Annex 1's impact on sterile manufacturing was dissected at PDA's Dublin workshop. Regulators stressed risk management, centralized control strategies, and the value of personnel knowledge.

  7. Collaboration, Local Knowledge Key To The Nordic Pharmaceutical Market 3/17/2025

    Companies looking to tap into the Nordic pharmaceutical market must recognize the unique blend of shared values and individual regulatory landscapes that define its unique approach to healthcare.

  8. Best Practices For Agnostic Document Processing In The TMF 3/17/2025

    Explores best practices for agnostic document processing in the Trial Master File (TMF), with insights on how to streamline workflows and enhance productivity.

  9. Evolving And Expanding Global Consulting With Local Expertise 2/3/2025

    Experts discuss global market expansion, emphasizing regulatory complexities, product lifecycle investments, and integrating local expertise to ensure successful product launches and long-term market sustainability.

  10. Legal Changes To Fortify Environmental Risk Assessment Of Pharmaceuticals 2/3/2025

    A new EU directive may require stricter environmental risk assessments for pharmaceuticals, impacting marketing authorization. Updated guidelines already in effect pose new challenges for companies.