What is Greenleaf Health

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.

WHO WE ARE: Greenleaf is guided by experts with a combined total of more than 250 years of FDA experience. Greenleaf’s decades of hands-on experience in the regulatory space is unmatched. The firm’s team of experts includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization. Learn More

WHAT WE DO: Greenleaf’s comprehensive services and wealth of experience ensure that clients can count on expert guidance as they navigate complex regulatory challenges. Greenleaf professionals work as teams specializing in product quality, manufacturing, and compliance; medical devices and combination products; and drug and biological products.

Product Quality, Manufacturing & Compliance

Greenleaf’s Product Quality, Manufacturing, and Compliance Team provides assistance and support to companies, trade associations, and other stakeholders regulated by the FDA. Greenleaf experts identify and promote practices and procedures that will align a client’s approach with the FDA’s quality, safety, and compliance expectations. Learn More

Medical Devices & Combination Products

Greenleaf’s Medical Device and Combination Products Team guides clients through the complete product lifecycle, from the earliest stages of product development, through the FDA submission and review process, to marketing authorization, postmarket requirements, and quality systems. Greenleaf applies extensive regulatory expertise to determine the best regulatory approach for a product and develop a comprehensive strategy to achieve a successful result. Learn More

Drug & Biological Products

Greenleaf serves as a trusted partner for companies navigating the complex process of bringing new therapeutics to market. The Drug and Biological Products Team specializes in clinical trial design, FDA submissions, the FDA review program, postmarket requirements, and more. Learn More

Advisory Services

Life sciences transactions involve a key component not found in other more routine commercial transactions ⎯ the product or company at issue is regulated by the FDA, and regulatory issues therefore must be carefully considered and appraised. A strong due diligence effort is vital to ensuring successful life sciences transactions. Learn More

Premarket Submission Support

To ensure success in today’s rapidly evolving life sciences industry, companies must recognize and be prepared for a dynamic regulatory landscape. Guided by decades of experience, Greenleaf’s team of experts delivers services that guide clients from early stage development to marketing authorization and throughout a product’s lifecycle. Learn More