An alliance has been announced which is bringing together leading experts in pharmaceutical regulation from both sides of the Atlantic. Schiff & Company Inc of West Caldwell, NJ, has joined forces with Pharmaceutical Development Services Ltd (PDS) of Nottingham, UK, to allow Schiff to offer PDS European regulatory expertise to its clients, while PDS will benefit from the worldwide contacts that Schiff will bring to the alliance. Schiff & Company will act on behalf of PDS clients in the United States for compliance activities and clinical studies. 

PDS will be providing Regulatory and Quality Services to Schiff & Company clients in Europe while Schiff & 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 & Company Inc, and Dr Michael Gamlen, Managing Director of Pharmaceutical Development Services (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 & 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".