Carolina Wirth focuses her practice on regulatory and administrative law matters primarily in the life sciences industry. She has experience providing regulatory counseling on food (including, food safety, ingredient reviews, labeling, and claims), dietary supplements, drugs (human and veterinary), cosmetics and medical device products (including medical device applications, general wellness products and telemedicine), to both domestic and international clients. Ms. Wirth also advises clients on compliance issues associated with the labeling, packaging, and advertising of foods, over-the-counter (OTC) drugs, cosmetics, dietary supplements.
Prior to joining the firm, Ms. Wirth was a principal of a law firm located in Sterling, Virginia where she advised clients on a wide variety of complex regulatory issues concerning products regulated by the Food and Drug Administration (FDA). Ms. Wirth also served as Senior Vice President for Regulatory Affairs at a veterinary regenerative medicine company in Middleburg, Virginia, where she was responsible for its overall strategy for obtaining FDA approval of veterinary stem cell products for various species and indications.
Previously, Ms. Wirth worked as a regulatory counsel in the Office of Regulatory Policy of the FDA’s Center for Drug Evaluation and Research (CDER) in Silver Spring, Maryland. Ms. Wirth also worked as an associate in the food and drug practice of an international law firm’s Washington, D.C. office where she concentrated her practice on matters pertaining to food, drugs, medical devices and cosmetics with a particular focus on regulatory issues relating to the conduct of clinical trials. Ms. Wirth also advised food clients on issues related to natural, organic, and gluten-free claims, and prepared FDA submissions, including GRAS self-affirmation, establishment registrations and product listings, and comments to proposed rules and guidance documents. She also has experience responding to Federal Trade Commission (FTC) and Better Business Bureau National Advertising Division (NAD) actions.
Ms. Wirth was recognized as a 2016 and 2017 Washington, D.C. "Rising Star" in the area of Food and Drugs by Super Lawyers magazine.
Ms. Wirth is fluent in Spanish.
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Boston University School of Law, J.D. (2002)
John Jay College of Criminal Justice, B.S., Criminal Justice (1999) magna cum laude
District of Columbia (2007)
New York (2003)
U.S. Supreme Court
Food and Drug law Institute, Member
American Bar Association, Section of International Law, Vice Chair, Latin America and Caribbean Committee (2016-2017)
Food and Drug Law Institute’s Food and Drug Policy Forum, Editorial Advisory Board, Member (2011-2012)
University of Florida, College of Pharmacy, Department of Pharmacy Health Care Administration, Associate Affiliate Professor
Author, FDA ConneKTion Blog
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