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 experts draw on a combined total of more than 250 years of FDA experience. The firm comprises a team of respected professionals including former leaders and regulatory experts from FDA, Capitol Hill, top global pharmaceutical companies, leading law-firms and the leading U.S. biotechnology trade organization. This wealth of experience informs Greenleaf’s understanding of the broad life sciences industry and allows the firm to deliver valuable insight throughout the product lifecycle. COMPREHENSIVE SERVICES & SUPPORT 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 specialize in product quality, manufacturing and compliance; medical devices and combination products; and drug and biological products. Product Quality, Manufacturing & Compliance Greenleaf experts identify and promote practices and procedures that will align a client’s approach with the FDA’s quality, safety, and compliance expectations. Drug & Biological Products Greenleaf serves as a trusted regulatory partner, advising companies on the complex process of bringing new therapeutics to market and guiding them through product lifecycle management decisions. Medical Device & Combination Products Greenleaf applies extensive regulatory expertise to guide medical device clients from early-stage development to marketing authorization and throughout the product lifecycle.
