Dr. Sharlin is a former FDA drug reviewer, an FDA regulatory expert witness (10 years) and an FDA compliance consultant (25 years) skilled in the regulations and submissions of drugs, biologics and medical devices. His experience includes 37 cases, 16 expert reports, and 8 depositions. He has never been successfully Daubert challenged. His cases have included, death or injury caused by drugs, biologics or medical devices, patents, insurance claims, wrongful termination, trade secrets, product labeling, and merger and acquisition He has broad and deep knowledge and experience as an FDA drug reviewer, biological scientist (Ph.D.), statistician, software, developer, data integrity specialist, technical writer, educator, and FDA regulatory expert. Over 50,000 people from more than a thousand FDA regulated companies have hired Dr. Sharlin to present one of the more than 40 FDA-related technical, regulatory and compliance classes he has developed.
Dr, Sharlin has extensive hands-on experience in the entire lifecycle of FDA-regulated product development, from creating an initial regulatory strategy, thru data collection and analysis, to review and approval at FDA.