(PRWEB) July 1, 2009
Represented in America by Dr. Jeff Rudolph, PDS will guide U.S. pharmaceutical companies wanting to develop into Europe, covering the major subject areas of regulation, quality management, European legal framework and the sourcing of local contractors for development.
Managing Director Dr. Michael Gamlen says, "Having established expert knowledge in European pharmaceutical development, we have built up a bank of expertise in our team that can considerably shorten the timescales and reduce the costs for American companies of introducing pharmaceutical products into Europe. Our business from U.S. companies has steadily increased and by opening a U.S. office with Dr. Jeff Rudolph as our main contact point, we are ensuring that we can effectively manage our expansion in the U.S."
U.S. national Dr. Rudolph is an experienced pharmaceutical scientist with over thirty years in the domestic and 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 or its predecessor companies where his responsibilities included V.P., International Pharmaceutical Development/R&D Operations. Recently, Dr. Rudolph has provided consulting services to the healthcare industry in the areas of CMC, process optimization, production troubleshooting, device design, organizational and business development as well as serving as an expert witness on formulation/drug delivery patent cases.
Dr. 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 U.S. customers.
Director of Regulatory Affairs, Janet Ellis says "It often comes as a surprise to our U.S. clients that there are so many different requirements with which the U.S.-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."
PDS is typically helping small and medium size U.S. pharmaceutical companies, as well as virtual companies, to undertake international expansion quickly and cost effectively. Michael Gamlen concludes, "Only the largest U.S. pharmaceutical companies employ a dedicated team to manage their European developments in clinical trials and product introduction. 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."
The U.S. office contact details are:
Phone Number - 803-476-4880
Fax number - 803-831-1899
Pharmaceutical Development Services
1632 Village Harbor Drive, Suite 400
River Hills, SC 29710
Notes for Editors
Pharmaceutical Development Services was founded in 2000 to provide consultancy in the areas of pharmaceutical and chemical development, quality services and regulatory affairs.
The company also provides training services in Quality by Design, medical device regulation and approval, CMC/Pharmaceutical Development issue resolution and the sourcing of hard to find chemicals and chemical intermediates.
PDS can also advise on the importation of biological products from the USA to Europe including assistance with logistics, product release, regulation and European law.
PDS operates from three centers of excellence: Nottingham UK, Beckenham UK and the USA.
In the UK, PDS can be contacted at
+44 (0) 115 912 4277
A photograph of Dr. Michael Gamlen is available from Media Contact
Andrew Third, +44 (0) 115 912 4350