Greenleaf Health Campus

About

Greenleaf Health stands as a premier FDA regulatory consulting firm, offering unparalleled strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies. Our mission is to support the development and manufacturing of innovative solutions that address critical global public health challenges.

Our team of experts brings together over 300 years of combined FDA experience, ensuring that our clients receive the highest level of expertise and integrity. Led by professionals who have excelled in both public and private sectors, we are dedicated to navigating the complex FDA regulatory landscape with precision and insight.

Clients benefit from our comprehensive services and extensive network of subject matter experts. We provide strategic advice on therapeutic product development, regulatory review, postmarket requirements, pipeline assessments, and preparation for FDA milestone meetings. Our guidance extends to medical devices and combination products, offering support in premarket strategic planning, submissions, and FDA interactions.

Additionally, we deliver full-service quality and compliance support. This includes on-site and remote compliance assessments, remediation efforts, inspection readiness, clinical quality systems enhancement, and supply chain optimization. With Greenleaf Health by your side, you can confidently navigate the regulatory process from start to finish.