Celeste advises clients on FDA and health care regulatory, compliance and enforcement matters. Celeste specializes in advising clients on FDA regulatory and transactional issues related to pre-clinical and clinical trials; marketing approval; product labeling; manufacturing and distribution; advertising and promotion; pharmacovigilence, biospecimens, and FDA inspections and enforcement actions. In particular, Celeste has significant experience with manufacturing issues and quality agreements. Celeste also advises clients on a broad range of health care regulatory matters, including: Medicare coverage of routine costs and medical devices in clinical trials, HIPAA, and state regulation of manufacturers, distributors and health care providers.