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Gary Messplay specializes in advising life science companies on regulatory and compliance matters. A partner in our FDA and Life Sciences practice, Gary represents leading pharmaceutical and medical device companies in a broad range of regulatory and compliance matters. Gary's clients include large multinational drug and device companies, as well as emerging companies.
Gary represents clients in matters relating to the regulation and commercialization of drugs, biologics, medical devices, food, cosmetics and tobacco by the Food and Drug Administration, the Department of Health and Human Services, the Department of Agriculture, the Drug Enforcement Administration, and other federal and state agencies. He counsels large multinational product manufacturers, as well as mid-size and emerging companies, on regulatory and compliance matters that involve the FDA, the HHS Office of Inspector General and other government agencies.
Gary has substantial experience in advising clients on all aspects of product launches and commercialization; leading product and compliance-related investigations; developing and implementing regulatory and healthcare compliance programs; and managing competitor disputes.
In addition, Gary regularly advises clients on complex regulatory and administrative law matters; compliance; advertising and promotion; specialty pharmacy programs; litigation; legislative initiatives; and due diligence in financings, mergers and acquisitions. He also advises clients on matters relating to healthcare fraud and abuse, clinical trials, drug safety issues, recalls, product approval issues, drug and device quality and manufacturing issues, and life cycle management. Counseling clients in responding to government and congressional investigations, as well as in transactional work related to FDA- and USDA-regulated products, is also a part of Gary's practice.
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.
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