Description
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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.
Greenleaf Leadership
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.
John Taylor
President and Principal, Compliance and Regulatory Affairs
Kathleen Sonntag
Chief Operating Officer
Daniel Schultz, M.D., F.A.C.S.
Principal, Medical Devices & 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
Kate Cook
Principal, Regulatory Policy
David Elder
Principal, Regulatory Compliance
Cynthia Schnedar
Principal, Regulatory Compliance
Maura M. Norden, J.D.
Senior Vice President, Medical Devices & Combination Products and General Counsel
Taryn Fritz Walpole
Chief of Staff
Executive Vice President, Regulatory Affairs
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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.
Compliance
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
Devices
Insight and guidance throughout the regulatory process for medical devices and combination products, including premarket strategic planning, submissions, and FDA meetings and engagement
Drugs
Strategic advice on therapeutic product development, regulatory review, and postmarket requirements, as well as pipeline review and FDA milestone meeting preparation
Cell & Gene Therapy
Specialized assistance with FDA interactions and submissions to support development, review, manufacturing, quality, and compliance for cell and gene therapies
Advisory Services
Regulatory risk assessments for life science investors — based on extensive research and due diligence, informed by Greenleaf’s deep regulatory knowledge
Litigation Support Services
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
To explore Greenleaf’s complete portfolio of capabilities and expert teams, view or download the PDFs below.
Greenleaf Health: Complete Capabilities
Greenleaf Health: Info Sheet
Services
Drugs
Devices
Compliance
Cell & Gene Therapy
Advisory
Litigation Support
Greenleaf is a regulatory consulting firm and does not provide legal advice or legal services.
1055 Thomas Jefferson Street, NW, Suite 450
Washington, D.C. 20007
202.609.8996 x5
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