A Trusted Partner
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.
Insight and Influence
Through their work as former leaders within the FDA, Greenleaf experts directly influenced significant policy decisions and regulatory actions of recent decades.
- The Centers for Devices (CDRH) and Biologics (CBER)
- CDER’s Office of New Drugs and Office of Compliance
- The Office of Regulatory Affairs and its headquarters offices
- The Office of Combination Products
- FDA’s Europe Office
- CBER’s Office of Tissues and Advanced Therapies
Designing, implementing, and guiding:
- New regulatory frameworks for emerging fields
- Global compliance and enforcement policy
- International science and regulatory policy efforts
- Emergency response measures
Invested in Your Success
Our unique expertise has helped companies navigate the complex FDA landscape for 15 years. Learn how Greenleaf’s teams work with clients to develop successful approaches to a range of regulatory scenarios.
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.
Patrick RonanCEO, Greenleaf Health and Vice Chair, Validant Group
John TaylorPresident and Principal, Compliance and Regulatory Affairs
Kathleen SonntagChief Operating Officer
Daniel Schultz, M.D., F.A.C.S.Principal, Medical Devices and Combination Products
John K. Jenkins, M.D.Principal, Drug and Biological Products
Robert J. Meyer, M.D.Principal, Drug and Biological Products
Karen Midthun, M.D.Principal, Drug and Biological Products
Sandra L. Kweder, M.D.Principal, Drug and Biological Products
David ElderPrincipal, Regulatory Compliance
Cynthia SchnedarPrincipal, Regulatory Compliance
Maura M. Norden, J.D.Executive Vice President, Medical Devices and Combination Products & General Counsel
Services at a Glance
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
Specialized assistance with FDA interactions and submissions to support development, review, manufacturing, quality, and compliance for cell and gene therapies
Regulatory risk assessments for life science investors — based on extensive research and due diligence, informed by Greenleaf’s deep regulatory knowledge
Support for stakeholders in communicating effectively about FDA regulatory policy issues and in understanding, implementing, and complying with the FDA’s regulatory programs
Strategic guidance in navigating and complying with the complex landscape of FDA regulations and policies related to digital health technologies
Expert opinions and FDA regulatory knowledge to support litigators and their clients in disputes related to medical devices, drug and biological products, and product quality, manufacturing, and compliance
Regulatory strategy, policy guidance, and compliance services for consumer products marketed in the cosmetics space