Carolina M. Wirth
Attorney | Washington, D.C.
Phone: (202) 780-2989 | Fax: (202) 370-9589
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About Carolina
Carolina Wirth provides regulatory and strategic counsel to companies involved in the development and marketing of pharmaceuticals, medical devices, cosmetics, dietary supplements and animal drug products and helps clients navigate the complex and ever-changing landscape of FDA regulation. Having served as regulatory counsel in the Center for Drug Evaluation and Research’s ("CDER") Office of Regulatory Policy at the FDA, Carolina is uniquely positioned to help clients understand the inner workings of the administrative process.
She works closely with domestic and international clients on compliance and regulatory concerns in the marketing, labeling, packaging and advertising of prescription and over-the-counter drugs, biologics, HCT/Ps, medical devices, cosmetics and animal products. She also serves as the legal representative for promotional review committees and routinely advises clients on issues related to the advertising and promotion of prescription drugs and medical devices, including review of brand promotional and non-promotional materials targeted to health care providers and patients, training materials, competitor issues and compliance with Federal Trade Commission laws and regulations.
During the COVID-19 public health emergency, Carolina assisted clients in preparing and submitting Emergency Use Authorization applications for medical devices and therapeutics, including in vitro diagnostic tests, personal protective equipment (including face masks) and a prophylactic drug product designed to prevent COVID-19.
