Monica Chmielewski

Monica R. Chmielewski is a member of the Health & Life Sciences Group and has more than 25 years of experience in life sciences, food and drug law, healthcare, pharmacy, and supply chain matters. She advises pharmaceuticals, biotech and medical device companies, health systems, academic medical centers, hospitals, physician groups, manufacturers and distributors, and pharmacies on regulatory compliance; transactional matters; clinical research; grants, grant administration, and compliance; product development and commercialization; and sourcing, manufacturing, and distribution issues. Her practice encompasses the full spectrum of life sciences and healthcare law, including clinical trial compliance, conduct and regulation, the structure and conduct of decentralized clinical trials, US Food and Drug Administration submissions and approvals, pharmaceutical and medical device manufacturing, licensing and commercialization, virtual care compliance, and corporate integrity matters.