Regulatory Insights

  1. Five Questions Biotechs Should Ask Before Selecting A Bioanalytical CRO 9/2/2025

    In a landscape where speed, quality, and trust are inseparable, choosing a CRO that shares your ambition is not optional—it is essential to survival and success.

  2. 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.

  3. The Resurgence Of Antibody-Drug Conjugates 9/1/2025

    As advancements in ADC technology and clinical trial methodologies progress, Antibody-Drug Conjugates (ADCs) are poised to become pivotal in precision oncology.

  4. 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.

  5. Navigating Project Optimus And The Rapidly Changing Oncology Development Landscape 9/1/2025

    Project Optimus and adaptive trial designs are reshaping oncology development, improving patient outcomes, and streamlining approval pathways.

  6. Accelerating Approval Pathway For Phase III Ovarian Cancer Trial 8/29/2025

    A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.

  7. Prioritizing Safety In Clinical Trials 8/27/2025

    This presentation explores organizational culture and the values that are essential to delivering high-quality safety oversight.

  8. 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.

  9. Navigating The Regulatory Complexities Of Targeted Medicines In Oncology 8/22/2025

    Explore the strategic considerations for successfully navigating the regulatory complexities of targeted medicines. Learn about the challenges in translational medicine and key clinical development considerations.

  10. Project Orbis Drug Registration 2025 8/22/2025

    Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.