What is Greenleaf Health?
Greenleaf Health is a leading FDA regulatory consulting firm that provides strategic guidance to pharmaceutical and medical device companies developing and manufacturing innovative solutions to pressing global public health challenges. With our distinctive blend of public- and private-sector experience, Greenleaf has the knowledge and expertise to guide select clients through the complex medical product development process and assist with critical product lifecycle management decisions.
Product Quality, Manufacturing & Compliance
- FDA’s recent shift from reactive to proactive compliance presents new challenges and opportunities for the private sector, making it important for companies to continue to build quality into their products.
- Greenleaf experts identify and promote practices that will align a client’s approach with FDA’s regulatory expectations. With strong quality management systems, companies can avoid lapses in quality and instead provide high-quality ingredients and components, rigorous manufacturing practices and processes, and a consistently reliable supply chain.
- In addition, by analyzing compliance issues and tracking FDA trends, Greenleaf helps companies navigate this new regulatory environment throughout every step in the process.
- Experts from Greenleaf’s Compliance team also provide advisory services that include extensive research and due diligence to firms engaged in potential mergers and acquisitions that require regulatory risk assessment before and after a life sciences transaction.
Medical Devices & Combination Products
- In a constantly changing regulatory environment, medical technology companies need a comprehensive, forward-looking strategy and a well-versed strategic partner to support the growth of their innovative technologies and successfully bring new products to market.
- Greenleaf delivers services that guide clients from early stage development to marketing authorization and throughout the product’s lifecycle. We offer critical guidance in key areas, including FDA filings, FDA’s review process, and postmarket requirements such as safety monitoring and quality systems. Greenleaf makes this possible by applying our extensive regulatory expertise, determining the best regulatory pathway for a product, and providing a comprehensive strategy to achieve a successful result.
- Greenleaf assists clients with all aspects of the regulatory review process for medical devices and combination products. In addition, Greenleaf has recently added medical device submissions to our portfolio of services, including the preparation of 510(k) and PMA submissions, as well as 513(g) requests, de novo petitions, and HUD, HDE and IDE applications.
- Experts from Greenleaf’s Medical Devices and Combination Products team also provide advisory services that include extensive research and due diligence to firms engaged in potential mergers and acquisitions that require regulatory risk assessment before and after a life sciences transaction.
Drug & Biological Drug Products
- With our in-depth knowledge and understanding of FDA as a regulatory agency, Greenleaf clients have a trusted partner in navigating the complex process of bringing new therapeutics to market. Our approach, firmly grounded in established principles of public health practices, is guided by our many decades of experience in drug and biological drug development, spanning all therapeutic areas.
- Our team delivers a variety of services from the earliest stages of product development through postapproval commitments. This includes monitoring and assessing the regulatory environment for emerging trends, potential impacts of agency actions on current development programs, and the competitive landscape for specific therapeutic areas.
- We specialize in clinical trial design, FDA filings, and the FDA review process, as well as postmarket requirements, including safety monitoring.
- Experts from Greenleaf’s Drug and Biological Drug Products team also provide advisory services that include extensive research and due diligence to firms engaged in potential mergers and acquisitions that require regulatory risk assessment before and after a life sciences transaction.
Our Unmatched Regulatory Expertise (The Greenleaf Team)
With decades of knowledge and insight into the regulatory space from both a public- and private-sector perspective, Greenleaf’s expertise is unmatched.
Our team includes former leaders and medical experts from FDA, Capitol Hill, top global pharmaceutical companies, and the leading US biotechnology trade organization.
Greenleaf is led by regulatory veteran Patrick Ronan, whose 20 years of leadership at FDA, on Capitol Hill, and at a top-tier global pharmaceutical company provides a comprehensive understanding of the healthcare sector to our firm and clients. The combined knowledge and extensive experience of the full Greenleaf team ensures clients can count on expert counsel through their toughest regulatory challenges.