Regulatory Insights

  1. CMC Strategies For Cell And Gene Therapy Development 7/2/2025

    The regulatory environment for cell and gene therapies (CGTs) is evolving rapidly, requiring sponsors to adopt a more strategic, integrated development approach.

  2. Project Optimus: Shifting Away From Maximum Tolerated Dose 7/2/2025

    Project Optimus represents a transformative shift in oncology, advocating for a more nuanced, evidence-based approach to dose selection, prioritizing patient safety alongside treatment effectiveness.

  3. Best Practices For Gene Therapy BLA/MAA Submissions 7/1/2025

    Medical writers completing gene therapy submissions require strategic placement, justification, and cross-referencing to fit unconventional data within a standard template.

  4. Expert Guidance For EU Gene Therapy And Companion Diagnostic Trial Regulations 6/27/2025

    This playbook provides a concise yet comprehensive roadmap for navigating Europe’s multifaceted regulatory environment when conducting gene therapy trials involving GMOs and CDx.

  5. Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration 6/26/2025

    A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.

  6. Disclosure Management System: Build Or Buy? 6/19/2025

    Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.

  7. Key Updates To Implementing Regulation (EU) 520/2012 6/18/2025

    The evolving pharmaceutical landscape demands continuous regulatory adaptation to safeguard patient safety and ensure compliance.

  8. How Sponsors Can Drive Success With Central eSource At Investigator Sites 6/17/2025

    Centralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.

  9. Validating Generative AI: A Framework For Reliability And Compliance 6/16/2025

    With structured CSA-driven validation and expert guidance, organizations can harness generative AI’s advantages safely and effectively, ensuring accuracy, compliance, and operational excellence.

  10. FDA Shifts Reshape Drug Development 6/13/2025

    Listen to regulatory leaders share CRO insights on how FDA changes are reshaping global clinical trials, sponsor strategies, and investment trends in a new podcast series debut.