Clinical Supply Regulation Resources

  1. IQVIA Labeling Compliance Solutions 5/16/2023

    Learn how by having a strategy for “core-to-carton” compliance, drug developers can avoid risks for patients and their company.

  2. Ensure Seamless, Efficient Delivery Of Clinical Trial Materials Worldwide 1/12/2023

    Drug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.

  3. A Smart Solution To Clinical Supply Management 10/28/2022

    Delve into a solution that ensures the efficient delivery of trial materials worldwide, while navigating the challenges of more complex study designs and the ever-evolving regulatory landscape.

  4. 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.

  5. Sponsor Overcomes Hold And Steers Products Through Development 11/2/2023

    Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.

  6. 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.

  7. Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change 3/9/2023

    A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.

  8. 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.

  9. Controlled Substances In Clinical Trials 3/30/2023

    Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.

  10. 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.