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Edwin Rivera-Martinez, Former Chief of the FDA’s International Compliance Branch, Joins PAREXEL Consulting Strategic Compliance Team
Date:11/4/2010

BOSTON, Nov. 4, 2010 /PRNewswire-FirstCall/ -- PAREXEL Consulting, a business unit of PAREXEL International (Nasdaq: PRXL) and a leading global consultancy serving the biopharmaceutical and medical device industries, today announced that Edwin Rivera-Martinez, B.S., M.B.A., former Chief of the U.S. Food and Drug Administration’s (FDA) International Compliance Branch, has been appointed as a Technical Vice President to its Strategic Compliance Services team, reporting directly to the Practice Lead.  This appointment further expands the Company’s global team of regulatory and compliance experts, which supports clients in navigating the increasingly complex regulatory environment and institutes proactive strategic compliance practices to help guide the success of their products.

Mr. Rivera-Martinez served for over 33 years at the FDA, including most recently as Chief of the FDA’s International Compliance Branch, within the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance, Center for Drug Evaluation and Research (CDER), which oversees human drug and active pharmaceutical ingredients (API) inspections conducted internationally by the FDA.  From December 2002 to July 2009, he served as Chief of the Manufacturing Assessment and Preapproval Compliance Branch in DMPQ, where he directed the Agency’s human drug preapproval inspection program.  In that role, he assured the validity of data in applications and Current Good Manufacturing Practice (CGMP) compliance of both domestic and foreign manufacturing establishments referenced in new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and supplements as well as biologics license
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