Dr. Hamrell is a pharmaceutical product development expert (Certification in Regulatory Affairs) who can assist you in evaluating the merits of a medical product liability claim, understanding that exactly goes on in drug approval, and what (side effects) adverse event reporting is all about.
I am an expert in pharmaceutical/biotech/medical device development and regulatory compliance issues. I have worked for over 30 years in drug product development and compliance, including working for FDA. I can assist you in the review, evaluation and assessment of licensing agreements, regulatory issues, compliance problems, due diligence, arbitration and mediation cases and all FDA-regulated areas.
MORIAH Consultants provides consultant expert witness testimony related to drug, biologic and device adverse reactions, product development issues and labeling claims. Our expertise in the broad area of pharmaceutical development, including the analysis of good clinical practices and regulatory affairs in clinical research. Dr. Hamrell also serves as a technical training expert for a large number scientific organizations.