Clinical Supply Regulation Resources

  1. 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.

  2. 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

  3. 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.

  4. A Practical Packaging Components Checklist For Emerging Biotechs 6/20/2024

    A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

  5. Clinical Research As A Delicate Ecosystem 4/18/2024

    Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors.

  6. Enhancing Quality And Efficiency Through Digitized Clinical Secondary Packaging Processes 6/1/2022

    Explore how an innovative software platform can be used to create customized, user-friendly applications to digitize clinical secondary packaging processes.

  7. The RMAT Designation: What It Means To The Advanced Therapy Supply Chain

    The RMAT designation gives the sponsor of a new drug access to increased meeting opportunities with FDA, in a manner comparable to those offered to sponsors of breakthrough-designated therapies. In fact the RMAT may be considered as analogous to the breakthrough designation for regenerative medicine drugs.

  8. Trade Compliance: Challenges In Global Biopharma Materials Logistics

    Have you noticed that it has become increasingly difficult to transport your material into and out of the United States? That’s because it has!

  9. 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? 

  10. 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.