Michael helps companies navigate the complex world of FDA-regulated drug and device development and product commercialization. He has experience with the many varied aspects of regulated human subjects research, particularly relating to clinical trial contracting. Michael helps clients negotiate clinical trial agreements, draft pre-clinical trial agreements and HCP consulting agreements. He also advises clients in other health law matters, including purchase and sell agreements and the creation of regulatory compliance and risk plans.
Before joining the firm, Michael was a consultant at one of the world’s largest pharmaceutical companies, where he was responsible for communicating its position on a variety of global contract issues.
Services & Industries
Government and Regulatory Affairs
Health Care
Health Care Compliance and Regulatory
FDA-Regulated Products
Research
Health and Life Sciences
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Articles in the National Law Review database by Michael B. Gastineau