MORIAH Consultants

MORIAH Consultants provides regulatory affairs and clinical research and complaince consulting to the pharmaceutical, device and biotech industries. The firm provides a full range of regulatory and clinical services including; regulatory strategic planning, preclinical pharmacology and toxicology assessment, clinical study design, clinical compliance audits, review/preparation of regulatory applications, representation and/or liaison with regulatory agencies and scientific groups, and expert witness services. The firm has dealt with Regulatory Authorities in numerous countries and supervised all aspects of product development and approval. Dr. Michael R. Hamrell, RAC, FRAPS, RQAP-GCP, CCRA, FACRP is the President of MORIAH Consultants, a Regulatory Affairs and Clinical Research consulting firm located near Los Angeles, CA. Dr. Hamrell has a unique background with over 30 years experience in regulatory affairs, clinical research and drug development with academia, the FDA, NIH and in industry. He also worked for over 5 years at the FDA and 3 years at the NIH in the Division of AIDS, coordinating the development of drugs, biologics and vaccine products for AIDS, oncology and anti-infectives. Dr. Hamrell has dealt with Regulatory Authorities in numerous countries and supervised all aspects of product development and approval.