Carolina is of counsel in the firm’s Food & Drug practice and is a member of the Dietary Supplements and Pharmaceuticals & Biologics industry teams. She provides clients with FDA regulatory guidance related to food, dietary supplements, drugs, cosmetics, and medical device products.
Carolina’s prior experience as regulatory counsel in CDER’s Office of Regulatory Policy at the FDA and as an in-house lawyer at a biotechnology company has aided her work with domestic and international clients on regulatory issues associated with the marketing, labeling, packaging, and advertising of conventional foods, prescription and over-the- counter (OTC) drugs, cosmetics, and dietary supplements. She also assists clients with Federal Trade Commission (FTC) and Better Business Bureau National Advertising Division inquiries. In addition, Carolina counsels clients on the clinical trial issues, including reviewing informed consent documents and master clinical trial agreements.
Prior to joining AGG, Carolina served as a food and drug regulatory attorney in private practice, including at Am Law 100 and 200 ﬁrms. She 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.