Dr. Hamrell has over 35 years of experience including time with FDA, NIH and private sector.  He’s conducted numerous audits of specialty laboratories, nonclinical testing facilities, large clinical laboratories and study specific testing procedures. He set up multiple Regulatory Affairs departments, developed regulatory plans, performed GCP, GMP and GLP audits, and managed the preparation of marketing applications for both domestic and international regulatory agencies. He prepared submissions for drugs, biologics and medical device products. He is RAC certified and holds a PhD in Pharmacology and BS in Biochemistry.