Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in drug development, clinical research and regulatory affairs for over 30 years. His is a leading expert in GLP compliance and inspection readiness and remediation, having conducted audits around the world at research labs, CTOs, and vendors. He has worked in pharmaceuticals, contract research, government, and biotech industries, in domestic and international regulatory affairs and clinical research. Dr. Hamrell also worked at the National Institutes of Health and as a reviewer in the Center for Drug Evaluation & Research at the Food and Drug Administration.
Dr. Hamrell has extensive experience in all aspects of product development, compliance, and audits in multiple areas. He has dealt with Regulatory Authorities and inspections in numerous countries and conducted and supervised all aspects of compliance audits and follow-up.