Clinical Supply Regulation Resources

  1. 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.

  2. Cut Through Complexity, Gain Speed, And Get Your Drug To Patients ASAP

    Discover top challenges that emerging biologics face, packaging containment offerings and services that help mitigate risks, and ways to reduce obstacles that slow development.

  3. 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.

  4. Enhancing Quality And Efficiency Through Digitized Clinical Secondary Packaging Processes 6/1/2022

    Explore how an innovative software platform can be used to create customized, user-friendly applications to digitize clinical secondary packaging processes.

  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. Is Your Clinical Supply Strategy Ready For EU CTR? 3/3/2022

    One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging? 

  7. Speed To Market – API Large-Scale Commercial Manufacturing 1/20/2022

    Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.

  8. Choosing RTSM? Evaluate The Team Running It, Not Just The Software 2/25/2026

    High-performing RTSM requires more than just code. Discover why team continuity and clinical expertise are the most overlooked factors in reducing trial risk and ensuring regulatory compliance.

  9. Clinical Trial Logistics Provider Of The Year

    How can you utilize state-of-the-art GMP-compliant depot networks and logistics hubs to maintain product quality and safety standards for complex therapies?

  10. European Clinical Supply Planning – Balancing Cost, Flexibility, And Time 3/13/2026

    By evaluating the key parameters of a study, sponsors can identify the most effective location for packaging and distributing clinical trial supplies.