Clinical Supply Regulation Resources

  1. 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? 

  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. Five Key Trends In CMC 3/18/2025

    CMC is evolving with digitalization, sustainability, supply chain resilience, post-merger integration, and personalized medicine.

  4. From Bench To Breakthrough: How Custom Kitting Fuels Precision Trials 4/27/2026

    Reduce trial variability and ensure protocol compliance with standardized custom kitting that transforms complex sample collection into a streamlined, strategic advantage for clinical success.

  5. Comparator Sourcing: How And Why To Choose A Provider

    The right comparator sourcing strategy is critical. Review what sponsors need to consider when selecting the right provider in order to source the needed commercial products.

  6. Clinical Supply Flexibility Where Biotech Programs Need It Most 8/10/2026

    Flexible clinical development requires scalable infrastructure, strong project management, and global logistics to ensure supply continuity and regulatory compliance.

  7. 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.

  8. Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And Solutions 12/8/2023

    Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.

  9. The Changing Landscape Of Oncology Drug Development 5/17/2022

    Discover the guidance for navigating unique formulation and handling requirements, novel trial designs and supply chain implications, and regulatory and clinical strategies to support product approvals.

  10. 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.