Helping A Sponsor Overcome A Partial Clinical Hold And Seamlessly Steer Multiple Products Through Development

Amid its clinical development phase, a biotechnology firm specializing in compact-sized operations enlisted the services of Veristat. They aimed to receive assistance with a groundbreaking cell therapy and immunotherapy product platform designed to combat various forms of cancer. Unfortunately, due to a series of chemistry, manufacturing, and control (CMC) inadequacies, one of the products was subjected to a partial clinical hold, triggering numerous information requests from the FDA for all the products within the platform.

In response to this challenge, Veristat's regulatory experts offered customized CMC support, facilitating the sponsor's progress. Uncover how Veristat was able to support the sponsor by accessing the case study below.