Client was planning to initiate clinical trials in USA for its lead oncology drug candidate. Client had no presence and experience with US FDA.
GRP has decades of experience in successfully obtaining approval for INDs and NDAs for complex therapeutic areas such as oncology, neuro, CVD among others. GRP provided a detailed roadmap for Client to plan and apply for clinical trials in with USFDA through an IND application. Since Client did not have any team in USA, GRP was trusted to manage entire lifecycle of the IND through the drug development process.