UK-based consultancy Pharmaceutical Development Services (PDS) has opened a US office in North Carolina to support a growing American client base.

Headquartered in Biocity Nottingham, PDS specialises in drug development outsourcing and quality assurance services for pharmaceutical and biotechnology companies. The new operation, headed by Dr Jeff Rudolph, will offer guidance to US companies looking to expand their European business. It will cover regulations, quality management, the European legal framework and sourcing of local contractors for product development.

“It often comes as a surprise to our US clients that there are so many different requirements with which the US-based companies must comply, in addition to coping with up to 35 different regulatory authorities,” noted Dr Janet Ellis, director of regulatory affairs for PDS.

According to managing director Dr Michael Gamlen, PDS has built up a “bank of expertise” in European pharmaceutical development that can “considerably shorten the timescales and reduce the costs for American companies of introducing pharmaceutical products into Europe”.

Typically this means small and medium-sized players as well as virtual companies. “Only the largest US pharmaceutical companies employ a dedicated team to manage their European developments in clinical trials and product introduction,” Gamlen said.

“Smaller firms have found that, by outsourcing to marketplace experts like the PDS team, they are sufficiently fleet of foot in terms of regulation, quality management, European legal issues and the sourcing of high-quality local contractors to be able to achieve time-to-market targets which compare very favorably, or in fact are superior to what the pharmaceutical giants can achieve.”

Jeff Rudolph is a US national with more than 30 years’ experience in the domestic and international development and management of branded, generic and OTC medicines. He has held senior pharmaceutical development positions at McNeil Laboratories and spent 23 years with AstraZeneca and its component companies.