What is Greenleaf Health

Greenleaf Health is a leading FDA regulatory consulting firm that provides strategic and technical guidance to pharmaceutical 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 200 years of FDA experience.  Greenleaf’s decades of hands-on experience in the regulatory space is unmatched. The firm comprises a team of experts including former leaders and regulatory experts from FDA, Capitol Hill, top global pharmaceutical 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’s experts lead 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 FDA. Greenleaf experts identify and promote practices and procedures that will align a client’s approach with FDA’s quality, safety and compliance expectations. Learn More

Medical Devices & Combination Products

Greenleaf’s Medical Devices and Combination Products Team delivers services that guide clients from early stage development to marketing authorization and throughout the product’s lifecycle. Greenleaf applies extensive regulatory expertise, determines the best regulatory approach for a product and develops 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 advising on the full product lifecycle, including clinical trial design, FDA filings, FDA review process, 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 FDA and regulatory issues therefore must be carefully considered and analyzed. A strong due diligence effort is critical to ensuring successful life sciences transactions. Learn More

Premarket Submission Support

To ensure success in today’s rapidly evolving medical technology 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