Regulatory affairs expert witnesses draw on careers in pharma, biotech, medical devices, and healthcare products to clarify compliance with FDA, EMA, and other regulatory frameworks. They evaluate submissions, labeling, quality systems, post-market surveillance, and risk management, and assess whether regulatory strategies, documentation, and decisions met applicable standards.
Sterile Compounding Pharmacy Expert Witness
Sterile Compounding Pharmacy Expert Witness
This highly-qualified expert has over 45 years of experience as a pharmacist, with experience in compounding pharmacy, including both federal and state regulatory and understanding third party relationships, such as PBM’s. He earned his BS in pharmacy from Ohio State University before beginning his career as pharmacy department manager in the retail pharmacy sector. He has formerly served as operations manager, operations director, and director of pharmacy and regulatory affairs and quality for AnazaoHealth Corporation. He has also served as the vice president of pharmacy and quality assurance for Wells Pharmacy Network and the president and general director of Physician Specialty Compounding. Currently, this expert is the pharmacist in charge at a sterile compounding pharmacy in Florida.
Pharmacist in Charge, A Sterile Compounding Pharmacy in FL
Bachelor of Science (BS), Ohio State University
Florida