WEST CALDWELL, N.J. & NOTTINGHAM, U.K.—Bringing together expertise in pharmaceutical regulation from both sides of the Atlantic Ocean, Schiff & Co. Inc. and Pharmaceutical Development Services Ltd. (PDS) have announced an alliance. This will allow U.S.-based Schiff to offer European regulatory expertise to its clients through PDS, while Schiff will act on behalf of PDS clients in the United States for compliance activities and clinical studies while also brining a list of global contacts from which PDS hopes to benefit.

More specifically, PDS will provide regulatory and quality services to Schiff clients in Europe while Schiff & Co. will target U.S.-based companies that are looking for local assistance in Europe. Such support would be provided in areas such as importation of clinical trials materials, generation and submission of clinical trial applications, ethics committee submissions, investigator brochures and more.

In addition, PDS supplies a contract qualified person release service for U.S.-based clients, and can act as local agent for medicines and medical devices registered in Europe.

"Our collaboration with PDS will provide important local knowledge about the challenging requirements for registering clinical trial materials and products in Europe, which is their primary expertise," says Dr. Robert Schiff, CEO and President of Schiff & Co. "PDS will also be assisting in the compilation of e-CTD (Common Technical Documents) documents on our behalf using their state of the art e-CTD software."

"Schiff & Company's extensive worldwide client base will offer us many opportunities to consolidate our position as a leading European regulatory consultancy, notes Dr. Michael Gamlen, managing director of PDS.