About Greenleaf Health Campus

Greenleaf experts draw on a combined total of more than 300 years of FDA experience to provide best-in-class strategic and technical guidance to companies navigating the evolving FDA regulatory environment.Greenleaf Health is a leading FDA regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.

Greenleaf is led by a team of professionals who have distinguished themselves in both the public and private sectors. We are committed to serving our clients with extensive expertise and unwavering integrity.With our comprehensive services and the wealth of knowledge available through our subject experts and network of technical specialists, clients can rely on unmatched guidance throughout the regulatory process.

Strategic advice on therapeutic product development, regulatory review, and postmarket requirements, as well as pipeline review and FDA milestone meeting preparation.Insight and guidance throughout the regulatory process for medical devices and combination products, including premarket strategic planning, submissions, and FDA meetings and engagement

Full-service quality and compliance support, from on-site and remote compliance assessments, remediation, and inspection readiness to clinical quality systems and supply chain optimization