Carolina M. Wirth

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Carolina M. Wirth concentrates her practice in matters involving products and companies subject to FDA regulation in the life sciences industry.  Ms. Wirth provides clients with regulatory guidance related to food, dietary supplements, biologics, drugs, cosmetics, and medical device products.

Leveraging her prior positions at the FDA, and as an in-house lawyer at a biotechnology company, Ms. Wirth works with domestic and international companies to prepare FDA submissions, and assist on compliance issues associated with labeling, packaging, and advertisting of foods, over-the-counter (OTC) drugs, cosmetics, and dietary supplements. Ms. Wirth also has experience responding to the Federal Trade Commission (FTC) and Better Business Bureau National Advertising Division inquiries on behalf of her clients.

Prior to joining the firm, Ms. Wirth was a food and drug regulatory attorney of an AmLaw 200 firm and also served as Senior Vice President for Regulatory Affairs at a veterinary regenerative medicine company, where she was responsible for its overall strategy for obtaining FDA approval of veterinary stem cell products for various species and indications.

Ms. Wirth was recognized as a 2016, 2017, and 2018 Washington, D.C. "Rising Star" in the area of Food and Drugs by Super Lawyers magazine and is fluent in Spanish.

Organizations/Memberships
  • American Bar Association, Section of International Law, Vice Chair, Latin America and Caribbean Committee (2016-2017, 2017-2018)
  • 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 (Fall 2011)

Practice

Industries

Related Media

Bar Admissions

  • District of Columbia, 2007
  • New York, 2003
  • United States Supreme Court, 2007

Education

Boston University School of Law, J.D., 2002

John Jay College of Criminal Justice, B.S., Criminal Justice, magna cum laude, 1999

Contact Address

1200 New Hampshire Avenue NW, Suite 710

, Washington, DC 20036-6802

Phone: 202.517.6317

Fax: 202.517.6322