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Expert Bio

Primary Area of Expertise

FDA Regulatory Affairs

Expert Witness Profile

Dr. Sharlin is a former FDA reviewer, and software development expert. He has 30 years of experience as an independent FDA regulatory consultant. He has provided FDA regulatory expertise to attorneys in cases involving;

• Death or injury caused by drugs/biologics/medical devices
• Patent infringement
• Insurance claims
• Trade secrets
• Product labeling
• Wrongful termination
• Stock fraud
• Contract disputes
• Data Integrity
• Bankruptcy
• Criminal violations
• Mergers and acquisitions

Based on his experience conducting regulatory training to over 40,000 staff at hundreds of FDA-regulated companies, he is skilled in explaining FDA related topics to juries. He has written 40 standard operating procedures on a wide variety of technical and regulatory topics. For three years he provided FDA regulatory insight to the Department of Defense on 18 products (drugs, biologics and medical devices) intended as defense against chemical and biological weapons. He has been deposed 16 times and testified 5 times.

Education & Licenses