Celeste Letourneau

Career

Celeste Letourneau helps biologic, device, and pharmaceutical manufacturers navigate the complexities of bringing groundbreaking products to market and provides comprehensive guidance to clients on the research, approval, manufacturing, advertising, and ongoing safety and surveillance of their products. Drawing on her knowledge as a nurse, as well as industry and private practice experience, Celeste is a go-to resource for FDA and health care regulatory, compliance, and enforcement matters across the product lifecycle.

Celeste is particularly experienced in advising clients on FDA regulatory issues related to drug development strategy, planning, and conducting of Phase 1–4 clinical trials, as well as marketing strategy, product approval, and post-marketing compliance. She offers extensive experience with initial and ongoing marketing strategies in light of the requirements under state health care laws as well as the FDA’s oversight of advertising and promotion.

Celeste also regularly helps domestic and international clients establish and manage large, multicenter trials from start to data lock, advising on issues such as site selection, enrollment, contracting, payments to health care practitioners, and subjects’ compensation. She also works closely with clients to resolve noncompliance with country-specific regulatory and contracting requirements.