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.
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.
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.
The rapidly-evolving drug industry calls for companies to stay current on regulatory analysis, regulatory correspondence, and FDA communications. Companies need to assess the regulatory market for emerging trends, potential future agency actions, and the competitive landscape for specific therapeutic areas. Navigating this marketplace calls for strategic management system.
Led by Rachel Sherman, MD, Principal, Drug and Biological Drug Products, Greenleaf’s drug team services span the earliest stages of product development and continue through to post-approval commitments. This includes total product lifecycle management for FDA-regulated companies. Through this approach, Greenleaf provides companies with the tools and management to make critical, real-time business decisions.