Featured Insights

  1. A Year Of Reflection And Preparation 1/3/2025

    The Trial Master File (TMF) landscape in 2025 will require companies to stay attuned to the evolving ICH E6(R3) guidelines and the full implementation of the CTIS.

  2. Navigating The Cell And Gene Regulatory Landscape 10/3/2024

    Navigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.

  3. Sterility Assurance With Louise Ui Fhatharta 1/17/2025

    This discussion explores critical aspects of maintaining sterility in pharmaceutical manufacturing, from facility design and environmental monitoring to regulatory compliance and common misconceptions.

  4. Unraveling The Complexity Of Cell Therapy: Advancements And Challenges 11/26/2024

    Cell therapy has emerged as a powerful tool for addressing critical medical challenges, but its rapid evolution necessitates a clear regulatory framework and consistent terminology.

  5. Pre-Launch Checklist - A Roadmap To Success 6/21/2024

    The path from groundbreaking therapy to readily available treatment requires a strategic approach. Delve into ten critical questions that can help you chart a successful course for your CGT therapy.

  6. Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ 1/6/2025

    The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.

  7. Strategic Management Of The Mature Product Portfolio 4/7/2024

    Explore a new outsourcing paradigm that integrates expertise, regulatory knowledge, efficiency, and cost containment, moving beyond traditional low-cost offshore staffing models.

  8. A Thoughtful Copay Program Design That Increased Patient Engagement 11/26/2024

    Learn how a partnership with a pharmaceutical company to redesign patient support materials resulted in increased patient engagement and copay program utilization.

  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.