Overview

Carolina Wirth provides regulatory and strategic counsel to companies involved in the development and marketing of pharmaceuticals, medical devices and animal products. Carolina recognizes the operational and financial considerations involved in creating and managing compliance and regulatory strategies and works seamlessly with clients to achieve their research and product development goals. She knows the challenges companies face in the current regulatory climate and is prepared to help find strategic solutions tailored to each client’s needs.

Carolina guides clients through the complex and ever-changing landscape of FDA regulation. With previous experience as regulatory counsel in the Center for Drug Evaluation and Research’s (CDER) Office of Regulatory Policy at the FDA, Carolina is uniquely equipped to help clients understand the inner workings of the administrative process.

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.

Faculty Positions

  • University of Florida, College of Pharmacy, Department of Pharmacy Health Care Administration, Associate Affiliate Professor (Fall 2011)

Credentials

Bar Admissions

District of Columbia
New York

Court Admissions

U.S. Supreme Court

Languages

Spanish

Education

Boston University School of Law
J.D. (2002)

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

Leadership & Community

Professional Associations

  • Regulatory Affairs Professionals Society (RAPS), Editorial Advisory Committee Member, 2021-present
  • FDA Alumni Association Activities Committee, 2018-present
  • American Bar Association, Section of International Law, Vice Chair, Latin America and Caribbean Committee, 2016-17, 2017-18, 2019-20
  • International Life Science and Health Law, Committee Member, 2017-present
  • Food and Drug Law Institute, 2015-present
  • Food and Drug Law Institute’s Food and Drug Policy Forum, Editorial Advisory Board, Member, 2011-12
  • Food and Drug Law institute Webinar Committee Member, 2018-20

Honors

  • Washington, D.C. Super Lawyers – Rising Stars, Food and Drugs, 2016-19
  • FDA Team Award – Office of Generic Drugs Bupropion Working Group, 2014

 Awards Methodology

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