Regulatory Insights

  1. Accelerating IND-Enabling Studies With Automated Bioanalysis Workflows 9/2/2025

    Reimagined as automation-first, bioanalysis shifts from being an Investigational New Drug (IND) bottleneck to a catalyst for innovation—helping companies move therapies forward with greater confidence.

  2. Writing An IND Module 3 For Cell And Gene Therapy Products 9/1/2025

    This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

  3. Why New Zealand Is Emerging As A Clinical Trial Hub 8/27/2025

    New Zealand is rapidly emerging as a premier destination for clinical research, offering a unique combination of regulatory agility, scientific expertise, and cost efficiency.

  4. Audit Trails And Transparency: Changes In Clinical Data 8/18/2025

    Audit trails are not only a regulatory necessity but a strategic tool to ensure data reliability and accelerate high-quality clinical research outcomes.

  5. LBPs: Unique Quality, Manufacturing, And Nonclinical Considerations 8/14/2025

    Live biotherapeutic products (LBPs) are emerging as a dynamic area of drug development, and their development demands tailored strategies that address both manufacturing and nonclinical complexities.

  6. Understanding Immunogenicity In AAV Gene Therapy 8/14/2025

    As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.

  7. Gene Therapy Studies Rose While Financing Declined In Q2 2025 8/13/2025

    There were three new approvals across the therapeutic landscape in the second quarter of 2025, but despite those positive signs, overall dealmaking was flat for the quarter.

  8. Demanding More From AI Governance In Drug Safety 8/13/2025

    Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.

  9. Building A High-Quality IND From Scratch With Strategic Gap Analysis 8/12/2025

    A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

  10. NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission 8/12/2025

    A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).