The client is a biotechnology company based in Taiwan that has developed novel gene therapy drug. The company conducted a Phase I study for their stem cell-based drug used in the treatment of Ischemic Limb Disease and wanted to submit an IND to FDA to conduct a Phase 2 study in USA based on phase 1 clinical results from Taiwan.
The client was seeking a USA based regulatory partner who can first act as its US agent and also have the expertise in the preparation and submission to FDA of INDs for Phase 2 clinical trial , using foreign clinical data .
GRP has many years of experience assisting foreign pharmaceutical and biotech companies register their INDs with FDA. For this client GRP provided the following services: