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Greenleaf Health

United States


Greenleaf Health Inc. (Greenleaf) is a leading FDA regulatory consulting firm that provides strategic guidance to FDA-regulated companies that are developing innovative solutions to pressing public health challenges. With its rare blend of public and private sector experience, Greenleaf has the experience to guide select clients through the medical product development process and successfully manage the product?s lifecycle. Greenleaf?s Product Quality, Manufacturing & Compliance Team provides assistance and support to companies, trade associations, and other stakeholders affected by new legislation and FDA policies. This includes clients aiming to actively participate in future policy initiatives relating to FDA?s regulatory and statutory authorities. Greenleaf?s Drug & Biological Drug Products Team has a robust blend of regulatory expertise and FDA institutional knowledge, allowing for critical guidance in an array of areas, including clinical trial design, FDA filings and review process, and post-market requirements such as safety monitoring. Greenleaf?s Medical Devices & Combination Products Team delivers service spanning the earliest stages of premarket production development and continue through the product lifecycle. The Greenleaf team comes from: Decades of FDA leadership, with up-to-date knowledge & expert insight to FDA operations Successful medical backgrounds Unparalleled public/private experience at: top global pharmaceutical companies; the leading U.S. biotechnology trade association; Capitol Hill

Areas of subspecialty

483 responses
Warning Letter Responses
Remediation Strategies
Labeling and Website Reviews
Audits and Gap Analyses
Mock FDA Inspections
Regulatory Submissions
Areas of service
  • North America