Ravi Harapanhalli PhD

Dr. Ravi Harapanhalli has been serving as Senior Vice President of Global Regulatory Affairs at Amneal Pharmaceuticals in Brookhaven, NY for the last two years. In this capacity, he oversees all regulatory affairs activities including submission of ANDAs, 505b2 NDAs, and regulatory meetings with FDA and other Health Authorities. He advises scientific teams on complex regulatory and technical issues facing high barrier generics including combination products and complex drug substances. Earlier, he worked at PAREXEL International for seven years, which included 4 years as Vice President of Technical Affairs; and he provided high-level consultations to the pharmaceutical/biopharmaceutical industry. Prior to that, he was at US FDA for over 11 years in the Office of New Drug Quality Assessment and worked through the ranks from being a CMC Reviewer to finally serving as Branch Chief in the last four years until July 2008. During his tenure at FDA, he supervised and reviewed various dosage forms and complex drug substances and combination products including modified-release dosage forms, implants, transdermals, MDIs/DPIs, liposomes, suspensions/dispersed systems, synthetic APIs, therapeutic proteins/peptides/MAbs, oligonucleotides, iron complexes, radiopharmaceuticals, etc. Before joining FDA, he was in academics for 8 years and in the pharmaceutical industry for 3 years. He frequently presents at national/international conferences; has published over 35 peer-reviewed articles, and holds four patents on tumor targeting and therapy from Harvard Medical School. He is a Diplomat of the American Board of Science in Nuclear Medicine and holds a Ph.D. in Synthetic Organic Chemistry from IIT Bombay.