Pharmanet

Client:	Mid-sized Japanese pharmaceutical company

Challenge:	Enter the U.S. market with a product already approved in Japan, but with no IND and uncertainty about how to proceed in the U.S.

Outcome:	PharmaNet Consulting medical and regulatory professionals reviewed available data, assembled an IND, and worked hand-in-hand with the client in designing the initial Phase II study. PharmaNet Consulting worked with the client to present results of the successful Phase II trial to the FDA, in addition to proposing a simplified Phase III study. This strategic approach focused the client’s development efforts and decreased the time and expense of entering the US market.