Founders

Michael Sharp, Ph.D

Dr. S. Michael Sharp has more than 40 years of experience as a regulatory affairs and clinical research executive. He has been consulting since 2012. His consulting practice includes advising young companies on regulatory strategy and assisting in the entire regulatory approval process. He also provides advice and assistance to companies with regulatory compliance issues, such as FD483 and Warning Letter Responses. He works primarily with medical device companies in a diverse range of therapeutic areas, including Ophthalmology, Orthopedics, Oncology and Ablative technologies. During his long career he has been a senior executive; including Senior Vice President for clinical and REgulatory Affairs, and Vice President of Regulatory and Medical Affairs. Dr. Sharp has held faculty appointments at several universities; most recently as Assistant Professor of Oncology and Director of Clinical Research at Emory University's Winship Comprehensive cancer Center. Dr. Sharp is an Elected Fellow of the Regulatory Affairs Professionals Society and the American Society for Laser Medicine and Surgery. zdfbn

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