Pharmaceutical Development Services (PDS) has opened a US office in South Carolina to support its clients across the pond.
PDS, which has operations in Nottingham and Beckenham, Kent in the UK, specialises in outsourcing and quality services for pharmaceutical and biotechnology companies.
Dr Jeff Rudolph will represent the company in the US and guide US pharmaceutical companies seeking European expansion, covering regulation, quality management, European legal framework and the sourcing of local contractors for development.
Dr Michael Gamlen, md of PDS, said: "Our business from US companies has steadily increased and by opening a US office with Dr Jeff Rudolph as our main contact point, we are ensuring that we can effectively manage our expansion in the US."
Rudolph is a pharmaceutical scientist with more than 30 year" experience of international development and management of branded, generic and OTC products. He held senior pharmaceutical development positions at McNeil Laboratories (J&J) and spent 23 years at AstraZeneca Pharmaceuticals.
Rudolph's depth of expertise and experience is mirrored within the PDS team including leading experts Dr Janet Ellis (Regulatory Affairs Director), Dr Simon Forster (Quality Management Consultant) and outsourcing expert Dr Ron Scott. Each brings an experienced focus to bear on the specifics of the European market on behalf of PDS's US customers.
"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. Expert advice from PDS will save them both time and money," says Ellis.
PDS typically helps small- and medium-sized US pharmaceutical companies, as well as virtual companies, to undertake international expansion quickly and cost effectively.