Cell and Gene Commercialization

  1. Have We Got Novel Drug Production And Compliance Timelines All Wrong? 6/13/2024

    Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.

  2. EMA Services: Ensure Regulatory Success 6/5/2024

    Get support for post-authorization regulatory requirements, spanning product launches, management of variations, new indications, line extensions, and ensuring ongoing compliance to uphold your product's regulatory status throughout its lifecycle.

  3. Comparing FDA's Accelerated Approval And EMA's Conditional Marketing Authorization 6/5/2024

    Gain an understanding of how expedited regulatory pathways can shape the development and approval of therapies for critical medical needs.

  4. Key Steps To Creating A Successful Market Access Strategy 6/5/2024

    Learn how to create a successful market access strategy and navigate the complexities of pricing and reimbursement in Europe.

  5. The Trifecta Of Promotional Review: What Is A PRC And What Do They Do? 6/5/2024

    The mystique of the Promotional Review Committee (PRC) is unveiled – understanding what it is and why you need it is crucial for ensuring a successful promotional review.

  6. The Essential Guide To Local Person For PV 6/4/2024

    For all marketing authorization holders, ensuring a functional pharmacovigilance system is crucial. Make sure you have the right Local Persons for Pharmacovigilance (LPPVs) in the right place at the right time.

  7. The QPPV: A Guide For The Qualified Person Responsible For PV 6/4/2024

    Ensure compliance with EU and UK pharmacovigilance requirements by setting up a robust PV system with a Qualified Person Responsible for Pharmacovigilance (QPPV).

  8. Accelerate European Market Access With MAA Submission 6/3/2024

    Discover how ensuring preparedness for Marketing Authorization Application (MAA) approval can streamline your application process and subsequent follow-up.

  9. GMP Services To Support Commercial Development 5/30/2024

    Expedite your development with our comprehensive suite of GMP services specifically designed to streamline regulatory and get you to market faster.

  10. Cell And Gene Therapy Center Of Excellence 5/28/2024

    By collaborating with your team to proactively identify and mitigate potential risks at every stage, we can expedite your product development timeline and enhance your prospects for commercial success.