Regulatory Insights

  1. 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.

  2. Navigating Global Health Policy In A Time Of Disruption 8/12/2025

    The healthcare industries in the U.S. and EU are undergoing significant regulatory and legislative changes. Learn how to better position yourself to navigate this complex environment.

  3. Thinking Ahead: How Integrated Development Plans Improve Product Success 8/12/2025

    How can integrated development planning reduce development timelines and increase your chances of commercialization success? Industry experts reveal how this approach helps avoid common pitfalls.

  4. How PIE Streamlines Biopharma And Payer Communication 8/12/2025

    Navigating pre-approval information exchange (PIE) with healthcare decision-makers is essential for market success. Learn what information can be shared and the best strategies for communication.

  5. 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).

  6. 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).

  7. Advancing Oncology Innovation With Adaptive Trial Designs 8/12/2025

    When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.

  8. Rescuing A Global Program For NDA Success 8/12/2025

    Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.

  9. Five Ways To Get Ready For IRT Regulatory Inspections 7/31/2025

    Preparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help.

  10. Managing Risk And Regulation In Clinical Trial Technology 7/31/2025

    Now is the time to evaluate your current risk management framework. Take action today to strengthen your safeguards, tailor your risk assessments, and prioritize transparent patient engagement.