Royce B. DuBiner Partner

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.

Royce is plugged in on the ground level in the evolving legal landscape of cannabis, psychedelics, and controlled substances. Advising clients on issues pertaining to cannabis transactions, Ketamine clinics, telehealth usages, psilocybin research, right to try initiatives, state regulation, product labeling, and operational compliance. He also advices the banking and debt finance industries on the direct and indirect funding of both Marijuana and Marijuana Related Businesses. He has advised and aided numerous banks in crafting policies and procedures for these emerging industries.

Prior to joining McGuireWoods, Royce served as an extern at INTERPOL, attorney law clerk at the EPA Office of Enforcement and Compliance Assurance (OECA), was the regulatory compliance specialist for an Institutional Review Board (IRB), and served as the Associate Counsel for Regulatory Affairs at a drug, medical device, and dietary supplement company. In this position, he oversaw all regulatory aspects from manufacture to marketing of the company’s products, including overseeing four successful branded pharmaceutical product launches.