Clinical Supply Regulation Resources

1. 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.

2. Lifecycle Planning For Containment And Delivery Of Biologics Drug Products 6/20/2024

   Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development.

3. 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? 

4. 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.

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. Navigating Audit Trail Data Regulations And Accessibility Changes 5/15/2024

   Data is the single most important thing in a clinical trial. Leverage the power of clinical trial data with effective utilization and access in a changing regulatory landscape.

7. 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?

8. Advantages Of Robotic Aseptic Processing 10/6/2023

   Examine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.

9. 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.

10. 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.