PDS will be providing regulatory and quality services to Schiff and Company clients in Europe while Schiff and Company will be targeting US-based companies 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 etc. PDS also supplies a contract qualified person (QP) release service for US-based clients, and can act as local agent for medicines and medical devices registered in Europe.

Dr Robert Schiff, CEO and president of Schiff and Company Inc, and Dr Michael Gamlen, managing director of PDS, Nottingham UK, announced the alliance at a launch event at Schiff’s New Jersey offices and both saw great opportunities in working together.

Dr Schiff said: “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. 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”.

Michael Gamlen said: “Schiff and Company’s extensive worldwide client base will offer us many opportunities to consolidate our position as a leading European regulatory consultancy. We look forward enormously to working with the new team. We are also very excited about meeting old clients and new at the AAPS meeting in November 2010 in New Orleans”.