Greenleaf’s respected regulatory experts have a combined total of more than 300 years of FDA experience and extensive knowledge of the life sciences sector. As leaders and implementers within the FDA, they directly influenced significant policy decisions and regulatory actions; as one of the foremost FDA regulatory consulting teams working with clients globally, they continue to shape the landscape of regulatory policy and medical product development.
A Rare Blend of Knowledge and Skill
With backgrounds spanning FDA regulation, policy, corporate regulatory strategy, law, technology, operations, and client relationship management, Greenleaf professionals use their collective skill to deliver a full-service engagement that supports our clients’ success.
- Led the FDA’s Center for Devices (CDRH) and Center for Biologics (CBER)
- Directed CDER’s Office of New Drugs, Office of Drug Evaluation II, and Office of Compliance
- Led the FDA’s Office of Regulatory Affairs and its headquarters offices
- Led the FDA’s engagement with Europe and the EMA
- Established and directed the Office of Combination Products
- Led CBER’s Office of Tissues and Advanced Therapies
- Designed and implemented new FDA regulatory frameworks for emerging areas of medical product regulation, including novel biomarkers and drug development tools, 510(k) medical devices, combination products, cell and gene therapies, and biosimilars
- Advised FDA commissioners and senior officials on pivotal questions of product review, enforcement, and regulatory policy
A Culture of Quality
- Directed the FDA’s pharmaceutical quality activities to protect the public from unsafe and ineffective drug products
- Led FDA policymaking for global compliance and enforcement, providing direction to 4,000+ staff across more than 90 countries
- Managed FDA inspection and enforcement field operations and pioneered the medical device inspection program
Crisis Response Experts
- Developed and managed the FDA’s emergency and crisis management functions
- Guided the FDA’s response to the influenza pandemic and other national health emergencies
Authoritative and Engaged
- Served in the U.S. Public Health Service, on the faculty of prestigious universities, and as expert advisors to scientific and medical bodies
- Frequently sought by litigators to provide expert opinions and testimony in an array of disputes involving medical device regulation and manufacturing
- Regularly publish and speak in important forums, advancing the field with original insight and analysis
Let’s Work Together
Greenleaf is dedicated to supporting life science companies with the highest quality of regulatory advice and insight. Please contact us to discuss your needs. We welcome the opportunity to work together toward your regulatory success.