background image



Greenleaf Health LLC is full-service regulatory consulting firm that provides strategic guidance to companies regulated by the Food and Drug Administration (FDA)  that are developing innovative solutions to public health challenges around the world. Greenleaf offers critical guidance by navigating companies through the regulatory process guided by teams specializing in product quality, manufacturing and compliance; medical devices and combination products; and drug and biological drug products.

Product Quality, Manufacturing & Compliance

To meet FDA’s mission of promoting and protecting public health, manufacturers are responsible for ensuring safe, high-quality medical products. With strong quality management systems, industry can avoid lapses in quality and instead provide: high-quality ingredients and components; rigorous manufacturing practices and processes; and a consistently reliable supply chain.

Led by John Taylor, Principal Compliance and Regulatory Affairs, and Mike Chappell, Principal, Regulatory Compliance, the Greenleaf compliance team has the expertise to identify and promote practices that will align a client’s approach with FDA regulatory expectations. FDA’s recent shift from reactive to proactive compliance presents new challenges for industry. For the first time, industry needs to build quality into the product. By analyzing compliance issues, Greenleaf navigates companies through this new regulatory environment. Click here to access Greenleaf Health’s 2013 Enforcement Report.

Click here for a comprehensive listing of Greenleaf’s compliance services.

Medical Devices & Combination Products

With the proper training and professional experience, Greenleaf advises companies on how to successfully bring new medical technologies to market. In a changing regulatory environment, medical device industry clients need ongoing monitoring and a full-service strategy to support their break-through services. With the right education, assistance and insight, companies can successfully bring medical devices from pre-market review to post-market safety requirements.

Led by Daniel Schultz, MD, Principal, Devices and Combination Products, Greenleaf’s medical device team offers critical guidance in areas, including FDA filings, FDA’s review process, and post-market requirements such as safety monitoring and quality systems. Greenleaf makes this possible by: leveraging expansive regulatory expertise; determining the best regulatory route for the product; and providing a comprehensive strategy for a positive path forward.

Click here for a comprehensive listing of Greenleaf’s device services.

Drug & Biological Drug Products

Greenleaf Health’s Drug and Biological Drug Products Group provides an array of consulting services throughout the various stages of product development and postapproval commitments. With our in-depth knowledge and understanding of FDA as a regulatory agency, clients can successfully navigate the very complex process of bringing new therapeutics to market.

Led by Rachel Sherman, MD, Principal, Drug and Biological Drug Products, our consulting group has the requisite expertise to assess the regulatory environment for emerging trends, potential impacts of agency actions on current development programs, and the competitive landscape for specific therapeutic areas. Our areas of expertise include clinical trial design; FDA filing and the FDA review process; and postmarket requirements, including safety monitoring. The team stands committed to providing clients with critical, real-time, business decisions deeply rooted in the fundamentals of established public health principles.

Click here for a comprehensive listing of Greenleaf’s regulatory drug services.