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Gary Messplay specializes in advising life science companies on regulatory, compliance and transactional matters. A partner in our nationally recognized FDA and Life Sciences practice, Gary has almost 30 years of experience representing large multinational pharmaceutical and medical-device companies, as well as emerging companies.
Gary advices clients in matters relating to the approval and commercialization of products that are regulated by the Food and Drug Administration and other federal and state agencies. Gary has substantial experience advising clients on all aspects of product approvals; product launches and commercialization including advertising and promotion; leading compliance-related investigations; developing and implementing regulatory and healthcare compliance programs; advising on patient support programs; and managing competitor disputes. In addition, Gary regularly advises clients on matters relating to healthcare fraud and abuse, clinical trials, informed consent, drug safety issues, product liability, recalls, responding to 483s, warning letters and complete response letters, drug and device quality and manufacturing issues, and life cycle management. Gary also represents companies in transactional matters including distribution and purchasing agreements, pharmacy agreements, clinical trial agreements, payor agreements, manufacturing and supply agreements, physician agreements, research agreements and co-promotion agreements.
Previously, Gary was in-house counsel at Eli Lilly and Company, where he had global legal, regulatory and compliance responsibility for the company's top-selling pharmaceutical product at the time.
A frequent author and speaker on regulatory and compliance matters, Gary has been recognized for multiple years by Super Lawyers Washington, DC.
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