Caroline advises clients on a wide range of regulatory and transactional matters, including:
- Pre- and post-market regulatory requirements
- General U.S. Food and Drug Administration (FDA) compliance matters, including preparing responses to warning letters and FDA Form 483 observations
- Regulatory counseling in connection with corporate transactions
Caroline supports clients in the pharmaceutical, biotechnology, medical device, and food sectors on complex regulatory matters involving FDA and other authorities. Her work includes advising on laws and regulations governing the development, approval, and commercialization of drugs, biologics, medical devices, and other health technologies, including FDA labeling and promotional requirements.
Caroline maintains an active pro bono practice, representing clients in matters involving immigration, veterans’ benefits, housing, and Social Security Income.
Before attending law school, Caroline worked in the office of Sen. Angus S. King, Jr. (I-ME) and at the Harvard T.H. Chan School of Public Health. While in law school, she served as an Executive Editor for the Virginia Law Review.