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Tim Felgate is a European regulatory consultant with over 20 years experience within multinational ethical pharmaceutical companies, contract research organisations and consultancy spanning a wide range of countries and projects. Before setting up Applied Regulatory Consulting Ltd in 2004, Tim was Director of International Regulatory Affairs for PRA International, where he more than doubled the size of the business and the team, retaining all staff. Prior to that Tim held key regulatory affairs roles for Chugai, BIOS (Consultancy and Contract Research) Ltd, Medeva, Wyeth Research and Rhône-Poulenc (originally May & Baker). Tim is also the founder of the regulatory intelligence sources website (www.reg-info.com), which began as a resource for personal use and is now used by the pharmaceutical community worldwide. Tim's education in physiology and pharmacology gained at both St Andrews University and University College London, together with his extensive regulatory affairs experience have equipped him to effectively manage a broad range of drug development and regulatory affairs projects. Tim can be contacted on +44 (0)118 978 2887 and by E-mail at . Specialties regulatory intelligence, regulatory strategy, authority meetings and hearings, Scientific Advice (European Medicines Agency and national authorities), SME registrations and support, regulatory submissions (eg. clinical trial and marketing applications), training interim management