Insights: News Releases Kilpatrick Townsend Adds Leading FDA Counsel in Washington, D.C.
Carolina M. Wirth Joins Firm
WASHINGTON, D.C. (June 29) – Kilpatrick Townsend & Stockton announced today that Carolina M. Wirth has joined the firm’s Washington, D.C. office as Counsel, adding to its Healthcare, Life Sciences & Technology and Mergers & Acquisitions and Securities Practices.
“We are delighted to welcome Carolina to the firm,” said Henry Walker, Kilpatrick Townsend Chair. “Her significant experience and background in the diverse areas of food, drug, cosmetic and medical devices strengthens the firm’s growing group of healthcare, life sciences and technology attorneys and reflects our commitment to these practice areas. Our clients will benefit greatly from Carolina’s expertise and her addition deepens our already strong team.”
Ms. Wirth focuses her practice on regulatory, administrative law and litigation matters primarily in the life sciences industries. She has experience providing regulatory counseling on food, drug, cosmetic and medical device products to both domestic and international clients. Ms. Wirth also advises clients on compliance issues associated with the labeling and advertising on drugs, cosmetics and dietary supplements.
Prior to joining the firm, Ms. Wirth was a principal of a law firm located in Sterling, VA, where she advised clients on a wide variety of complex regulatory issues concerning products regulated by the Food and Drug Administration (FDA). She also served as Senior Vice President for Regulatory Affairs of 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.
Previously, Ms. Wirth worked as a Regulatory Counsel in the Office of Regulatory Policy of the FDA’s Center for Drug Evaluation and Research (CDER). While at the CDER she participated in rulemakings, the development and drafting of guidance documents, and worked with various CDER offices in responding to Citizen Petitions. Ms. Wirth also worked on a variety of matters, ranging from issues related to bioequivalence of generic drugs to marketing of over-the-counter drugs approved under a New Drug Application.
Ms. Wirth received a J.D. from Boston University School of Law, and a B.S. in Criminal Justice, magna cum laude, from John Jay College of Criminal Justice.
“I am honored to be joining Kilpatrick Townsend and look forward to working closely with the entire Kilpatrick team,” said Carolina M. Wirth. “I know that I am joining a firm that puts client service first, encourages collaboration and serves an impressive and expanding client base that complements and supports my growing practice.”
For more information about Kilpatrick Townsend, please visit: www.kilpatricktownsend.com.
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