Clinical Supply Regulation Resources

  1. Investigational Medicinal Products: Labeling Changes And Their Implications 12/16/2022

    Learn about Annex VI, which covers changes in the labeling requirements for investigational medicinal products (IMPs) and harmonizes them throughout EU countries.

  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. Artificial Intelligence Regulation 12/13/2024

    To make the best use of artificial intelligence (AI), drug sponsors need to understand where health authorities are drawing the lines.

  4. 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.

  5. Overcoming Obstacles To Deliver Critical Autologous Cell Therapy 3/25/2023

    See how teams ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy, from the U.S. to a manufacturing site in Germany

  6. What Does 2025 Hold For Pharma? 1/17/2025

    Look at what’s in store for pharma and life science in 2025. While we see many recurring themes, 2025 promises to be filled with unexpected — and possibly unprecedented — developments.

  7. Packaging And Labeling Support For A Global Cell Therapy Program 8/10/2026

    Master complex cell therapy logistics with coordinated depots, purpose-built labeling, and temperature-controlled solutions that protect product integrity.

  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. IMP Labeling: EU CTR Transition Considerations 6/26/2023

    Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.

  10. Global Clinical Supply Solutions For Every Trial

    A reliable clinical supply chain strategy is as essential as a company’s discovery program. Seek a partner who can help guide a comprehensive  strategy and manage day-to-day activities.