About

Marc represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device and drug industries. He also teaches as part-time adjunct professor at Northeastern University on regulatory topics including US and international food law and regulation.With a focus on international trade, he advises clients on the regulatory requirements and strategic corporate considerations that affect the importation, distribution and exportation of FDA regulated products. Marc is a frequent national speaker on FDA compliance issues affecting the food, dietary supplement, and medical device industries. He is also considered a leading voice in understanding the Food Safety Modernization Act, which has fundamentally changed food law in the U.S., with interviews and contributions in the Washington Post and Huffington Post. Specialties: FDA/Food Drug & Cosmetic Act: food, LACF food, dietary supplement, OTC drug, medical device and animal.; Common Activities: 483 response & compliance w/21 CFRs, Warning Letters, Letter of Guaranty/Assurance, Imports, Cross Border Agreements (supplier, licenses etc.), Medical Device Submissions (PMA, PDP, HDE, IDE/IRB, 510k), Interface w/FDA; International Submissions (ANVISA, COFEPRIS, CE), Registrations, Import Alert Petition.Full range of FDA representation.

Practices Areas

International Law

Language

English

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