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Case Study:

Regulatory Affairs #3

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Client:

A small San Diego based biotechnology organization with clinical stage photoimmunotherapy products.

Key Issues:

Our client was looking to engage new external vendor partnerships with CRO’s and other service providers to support their rapid growth. The company had received fast track designation and would require a substantial amount of additional resources to prepare for several large Global Ph.III trials. The small Regulatory team was in need of a variety of Clinical, Non-Clinical and CMC related support. Furthermore, existing Quality SOP’s were deficient and as the client’s clinical programs continued to grow rapidly, so compliance with requirements was also a concern.

Solution:

The client did not have time to play an active role in the team selection process, so BioPoint utilized an internal Regulatory SME to pre-screen all potential resources for final approval by the company RA team. Once the team was selected, the BioPoint Regulatory SME played an active role in team management throughout the 14 month engagement.

The BioPoint team was comprised of: BioPoint Regulatory Lead(VP Level), 3 Clinical Regulatory Managers to support 9 CTA’s , 2 Regulatory CMC Managers to author Module 2 and 3 for US, EU and RoW, Regulatory Project Manager to support CMO activities and 3 CMC Tech writers.

Additionally, BioPoint was able to support the Quality group in unison with: 1 Quality Director, 2 GMP SOP Writers and 2 document control specialists. These resources worked both onsite and remotely, as each project required.

Conclusion:

BioPoint’s team helped client’s Regulatory group adhere to regulatory standards, implement effective manufacturing agreements, and be in a position to more efficiently manage clinical activities with their growing team.