Clinical Supply Regulation Resources

  1. 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.

  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. Optimized Laboratory Kitting Is Key To Successful Clinical Trials 5/18/2022

    Clinical trials can be completely derailed by the absence of a single component, a lack of clarity in labelling, or errors in temperature-controlled logistics.

  4. 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? 

  5. 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.

  6. 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.

  7. Benefits Of Electronic Labels: Investigational Medicinal Products 12/2/2022

    When a new therapeutic drug, medical device, vaccine, or other investigational medicinal product (IMP) is developed, learn why a label must be on its packaging that provides relevant and important information.

  8. 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.

  9. Clinical Manufacturing: What It Is And How It Works 2/27/2022

    Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?

  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.