Jan Sedgeworth, PhD has over seventeen years of experience in the pharmaceutical and biotechnology industry. Dr. Sedgeworth has held executive positions in regulatory affairs at SmithKline Beecham, GlaxoSmithKline and Hemosol. Over a period of 8 years with SmithKline Beecham, Dr. Sedgeworth was responsible for the approval of more than 18 New Chemical Entities in Canada in a variety of therapeutic and product areas, including CNS, cardiovascular, diabetes and vaccines. At Hemosol, Dr. Sedgeworth was responsible for worldwide regulatory affairs, focussing on FDA, MCA and Health Canada. In 2003, Dr. Sedgeworth formed Carexa Inc., providing consulting services to the pharmaceutical and biotechnology industries.Joan C. Pehta, MD is a seasoned medical and regulatory professional in the pharmaceutical industry. Prior to forming the consulting company The Alpha Bio Group in 2000, Dr Pehta was responsible for Clinical and Medical Affairs for 10 years at V.I. Technologies, Inc. where she was instrumental in the clinical development and US licensure of a novel viral inactivated blood product, SD Plasma. In addition, Dr Pehta directed clinical operations, medical safety, clinical regulatory affairs, and medical marketing. Dr Pehta has extensive experience with the FDA including an indepth knowledge of regulations for drugs and biologics for human use, and requirements for establishing and maintaining regulatory compliance for the conduct of clinical research

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Website: http://carexa.com/