Clinical Supply Regulation Resources

  1. Quality Assured: Bringing Life-Changing Therapies To Patients 1/12/2023

    Biopharmaceutical drug development remains a key trend, demanding specific expertise and capabilities when it comes to quality assurance. Explore four trends that matter in biologics for clinical trial supply.

  2. Creating Accurate, Efficient, And Effective CDMO Project Proposals 8/15/2023

    To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.

  3. AI-Driven Signal Management: The Future Of Drug Safety 12/19/2025

    By combining autonomy with robust governance, agentic AI enables pharmacovigilance teams to move from reactive to proactive safety management, anticipating risks before they materialize.

  4. 5 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.

  5. Highly Potent, Perfectly Packaged 1/12/2023

    Experts explore a project to add a contained manufacturing facility and potent packaging suite by discussing the attention to technical detail required to exceed the required high standards and regulatory controls.

  6. Sample Sizes For Performance Testing Of Combination Products, Packaging 5/16/2025

    When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

  7. How Regional Logistics Strategy Supports Clinical Success In Europe 3/4/2026

    In an era where trial delays, customs bottlenecks, and fragmented regulations can derail even the most promising program, logistics has become a strategic asset.

  8. Transforming The Pharma Supply Chain 7/17/2023

    Start leveraging logistics partners with global end-to-end solutions that can help avoid costly delays, ensure high product quality, and accelerate impactful solutions for patients worldwide.

  9. Cold Chain Shipping Considerations: Understanding Passive Shippers

    Learn more about the design and performance of passive shippers and how different material and coolant configurations can impact the cost and efficacy of your shipping solution.

  10. Optimizing Clinical Trials In China With Strategic Solutions For Supply Chain 3/12/2026

    Plan proactively for clinical trials in China by aligning with National Medical Products Administration requirements and leveraging Free Trade Zones to streamline regulatory approvals and clinical supply importation.