Royce B. DuBiner advises pharmaceutical, medical device, dietary supplement, food and beverage companies as well as private equity firms on a range of regulatory matters. He has experience handling complex issues arising with drug scheduling, controlled substances, FDA audits, importation issues, product promotion, product liability issues, labeling, government pricing, wholesale drug sales, ingredient acquisition, current good manufacturing practices (cGMPs), PhRMA and AdvaMed Code.
Royce also advises both buyers and sellers on the regulatory risks of healthcare and life sciences transactions. Prior to joining McGuireWoods, Royce has worked for an Institutional Review Board and has 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.
His past in-house experience gives him insight into the complex mechanics and challenges healthcare and life sciences companies face in growth, compliance, supply, marketing, and manufacturing. He blends legal strategy with business sense to construct practical solutions that match the needs of clients in these heavily regulated industries.
In addition to his current practice, Royce handles pro bono cases for veterans in order to seek benefits for injuries sustained in service and correct service records.
- Advised multiple publicly traded life sciences companies and private equity funds in mergers and acquisitions, conducting comprehensive due diligence to spot and correct problems.
- Part of deal team representing employer in regulatory due diligence two separate transactions each valued over $50 million dollars.
- Trained pharmaceutical sales representatives on current law as it relates to the promotion of drug products.
- Effected change at the local level and in public meetings advocating for policies to advance the ability to market pharmaceutical products.
- Regulatory counsel on three separate Lanham Act cases involving false claims for drug and supplement products.
- Created a comprehensive product legal and regulatory database for company for current products and labeling.
- Emory University School of Law, LLM, 2015
- University of Denver Sturm College of Law, JD, 2013
- Goucher College, BA, History, magna cum laude, 2010
- District of Columbia
- U.S. Court of Appeals for Veterans Claims
Rate : $$$