Carolina M. Wirth

About Carolina

Carolina Wirth is an FDA regulatory attorney who advises life sciences companies, hospitals and health care systems, and providers on regulatory strategy, enforcement risk and practical compliance solutions across the product lifecycle.

Drawing on her experience as regulatory counsel in the Office of Regulatory Policy (“ORP”), Center for Drug Evaluation and Research (“CDER”) at the Food and Drug Administration (“FDA”), Carolina brings a practical understanding of agency expectations and enforcement approaches. She helps clients navigate complex and evolving regulatory requirements and provides advice that is both legally sound and operationally practical. She collaborates closely with legal, regulatory and business stakeholders to support product development, commercialization and risk management strategies.

Carolina’s practice includes:

• Advising on FDA regulatory strategy across the product lifecycle, including product classification, jurisdiction and commercialization considerations for drugs (Rx and OTC), biologics and medical devices, including digital health technologies;
• Assessing enforcement risk and guiding responses to FDA actions, including inspections, warning letters, recalls and government investigations, and developing corrective action plans;
• Providing practical guidance on product development, distribution and commercialization to support compliant market entry and ongoing operations;
• Counseling on advertising, promotion and labeling requirements, including compliance with FDA and FTC requirements;
• Advising on regulatory strategy for foods and cosmetics, including classification, regulatory status, labeling and commercialization considerations;
• Advising on complex regulatory issues, including compounding, vaccine policy and the adoption and regulation of artificial intelligence–enabled products; and
• Advising on clinical trials, including review of clinical trial agreements, informed consent documents and related regulatory requirements.