Regulatory Sciences

  1. Mandatory HTAR Implementation In The EU: Part 2 9/17/2024

    Here, we provide guidance on how to prepare for the new HTAR requirements and ensure successful compliance for your product launch.

  2. Mandatory EU HTAR Implementation: Part 1 9/17/2024

    Discover how to prepare for the EU Health Technology Assessment Regulation (HTAR), effective January 2025, to ensure a successful product launch.

  3. How To Successfully Prepare For The HTAR Implementation In The EU 9/17/2024

    The European Health Technology Assessment Regulation (HTAR) will significantly impact the market access process in Europe. See how HTDs can prepare for the upcoming joint clinical assessments.

  4. MLR Submission Content: Setting Yourself Up For A Successful PRC Review 9/17/2024

    A well-prepared MLR submission is crucial for efficient PRC reviews. It ensures timely and effective review processes and reduces unnecessary delays.

  5. Highlights From FDA's Analytical Test Method Validation Guidance 9/17/2024

    The FDA has updated its guidance on analytical test method validation, aligning with ICH Q2(R2). Review key changes including streamlined requirements, focus on critical parameters, and flexibility.

  6. FDA Animal Rule: Overview And Impact On Drug Development 9/17/2024

    Streamline drug approvals using the Animal Rule, which allows for well-controlled animal studies when human trials aren't possible. Learn more about this expedited pathway.

  7. The Moving Regulatory Landscape For Gene Therapy Trials In EU: Part 1 9/17/2024

    The Clinical Trial Regulation (CTR) harmonizes clinical trial applications (CTAs) in the EU, but doesn't cover GMO applications for gene therapy studies.

  8. The Moving Regulatory Landscape For Gene Therapy Trials In EU: Part 2 9/17/2024

    The SNIF form, a crucial part of GMO applications for clinical trials with GTMPs, now requires separate submission through the ESFC platform.

  9. Advertising & Promotional Review Consulting 8/29/2024

    ProPharma has built the world’s leading and first full-service global solution dedicated to Advertising & Promotional Review. 

  10. European Regulatory Development 8/29/2024

    Scientific knowledge to strategize viable and efficient drug and device development pathways to achieve successful outcomes.