ROYCE B. DUBINER practices food and drug law with a focus on advising pharmaceutical, cosmetic, medical device, cannabis, dietary supplement, tobacco, food and beverage companies as well as investment firms on a range of regulatory matters. He is presently the co-lead of the Cannabis, Hemp, and CBD industry team. Royce has experience handling complex transactions, investigations, and litigation arising in industries regulated by FDA, Customs and Border Protection (CBP), USDA, DEA, FTC, EPA, state cannabis regulators, board of pharmacy, Alcohol and Tobacco Tax and Trade Bureau (TTB), and United States Centers for Medicare and Medicaid (CMS). As a transactional lawyer Royce provides deal-oriented risk assessment when acquiring companies in the life sciences space as well as food and beverage companies. Including advising underwriters and commercial banks on risk points in financing transactions. He frequently advises on the financing and acquisitions of Clinical Research Organizations (CROs), Pharmaceutical Companies, Medical Devices Companies, Food and Beverage Manufacturers, Distilled Spirit Manufacturers, and Pharmaceutical Services providers. He has both the regulatory and litigation background to assess both present transaction risk as well as go forward plans post-close. Royce’s regulatory background allows him to understand key risk points and touch points between multiple State and Federal agencies. He has actively investigated drug diversions, whistleblower reports, as well as advised on coordinated settlements and mitigations strategies resulting from government inspections at both the port of entry and factory. He has experience reviewing clinical trial compliance, human subject protection, advising IRBs and IAUCs as well as assisting in adverse event responses. Royce has significant experience with FDA and DEA enforcement matters including crafting response and criminal violations of the Food Drug and Cosmetics Act (FDCA) and Controlled Substances Act (CSA). In a litigation capacity Royce serves as a counsel who understands the defense of client’s products, their goals, marketing and labeling, as well as the strength of the brand. He has worked to defend companies at all stages of litigation in both product liability and labeling class actions. Working with class-action and product liability colleagues to understand the regulations and products.