Carolina’s work with domestic and international clients on compliance and regulatory concerns in the marketing, labeling, packaging and advertising of prescription and over-the- counter (OTC) drugs, biologics, HCT/Ps, medical devices and animal products benefits from her service as part of the executive team of a veterinary regenerative medicine company. As the senior vice president for regulatory affairs, Carolina was responsible for the organization’s overall strategy for obtaining FDA approval of veterinary stem cell products for various species and indications. Carolina has served as the legal representative for promotional review committees (PRCs) 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 healthcare providers and patients, training materials, competitor issues, and compliance with Federal Trade Commission (FTC) laws and regulations.
Carolina counsels clients navigating the clinical trial process — advising regarding data integrity and human subject protection as well as assisting with strategic advice and day-to-day needs for implementation, such as clinical trial agreements and informed consent documents.
During the COVID-19 public health emergency, Carolina has assisted clients in preparing Emergency Use Authorization applications for medical devices and therapeutics, including in vitro diagnostic tests, personal protective equipment and a prophylactic drug product designed to prevent COVID-19.
- University of Florida, College of Pharmacy, Department of Pharmacy Health Care Administration, Associate Aﬃliate Professor (Fall 2011)