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’s team is comprised of 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 review process, to marketing authorization, postmarket requirements, and quality systems. Greenleaf also provides litigation support and expert witness services to FDA-regulated companies and their outside counsel.  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 providing strategic and technical guidance on medical product development, regulatory review, and postmarket requirements. Learn More

Cell & Gene Therapy

Greenleaf assists sponsors of cell and gene therapies by optimizing FDA interactions and submissions to support development, manufacturing, quality, compliance, and regulatory review. Experts from the Drug and Biological Products Team work together with the firm’s Product Quality, Manufacturing, and Compliance Team to provide comprehensive technical and strategic guidance to companies maneuvering the sophisticated regulatory landscape for cell and gene therapy. Learn More

Real-World Evidence

RWE has the potential to accelerate the development of new treatments, provide physicians with unmatched insights, support coverage decisions, and optimize patient care. Companies prepared to employ the power of RWE will require more than just raw data — that’s why Greenleaf has partnered with Trio Health to provide a cutting-edge combination of technology and regulatory insight. 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