ROCHELLE, Va., Dec. 12, 2018 /PRNewswire-PRWeb/ -- NDA Partners Chief Executive Officer Earle
Dr. Shah was formerly a Senior Research Scientist in the Office of Pharmaceutical Sciences at the US Food & Drug Administration (FDA). During his 30-year tenure at the FDA, he developed several regulatory guidelines with "How-to Information" in the areas of bioanalytical method validation, dissolution, bioavailability/bioequivalence, scale-up, and post approval changes (SUPAC), and led efforts to establish the scientific basis for the Biopharmaceutics Classification System (BCS).
"I am deeply honored to receive this award for my contributions to advance the development and quality of drugs and therapies in developing countries and around the world. It is my passion to help advance the development of treatments that assist in addressing today's global health challenges," said Dr. Shah.
Dr. Shah joined NDA Partners as an Expert Consultant in 2016. In addition to his thirty years of experience at the FDA, he is a former Biopharmaceutics Expert Committee member of the United States Pharmacopeial Convention (USP), where he was Co-Chair of USP's Advisory Panel on Dosage Form Performance Topical/Dermal, and Distinguished Pharmaceutical Scientist/Consultant at USP in Biopharmaceutics. He is a member of the Steering Committee of Non-Biological Complex Drugs (hosted at Lygature, The Netherlands), and Founder and Chairman of the Society of Pharmaceutical Dissolution Science (SPDS) International. Dr. Shah has authored more than 300 scientific papers and four books. His honors include the AAPS Presidency, AAPS Distinguished Service Award, AAPS Distinguished Pharmaceutical Scientist Award in 2017, and the Pharmaceutical Sciences World Congress (PSWC) Research Achievement Award. He is a recipient of International Pharmaceutical Federation (FIP) Lifetime Achievement Award in Pharmaceutical Sciences and holds an Honorary Doctorate from Semmelweis University and from the University of Medicine and Pharmacy Carol Davila, Bucharest, Romania.
About AAPS The American Association of Pharmaceutical Scientists (AAPS) is a professional scientific organization of approximately 9,000 members employed in academia, industry, government, and other research institutes worldwide. Founded in 1986, AAPS advances the capacity of pharmaceutical scientists to develop products and therapies that improve global health.
About NDA Partners NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.
Contact Earle Martin, Chief Executive Officer Office: 540-738-2550 MartinEarle(at)ndapartners(dot)com
SOURCE NDA Partners, LLC
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