OUR EXPERIENCE.
YOUR SUCCESS.
Greenleaf experts draw on a combined total of more than 300 years of FDA experience to provide best-in-class strategic and technical guidance to companies navigating the evolving FDA regulatory environment.
FORMER FDA SENIOR OFFICIALS JOIN FIRM
Sandra Kweder, M.D., former Deputy Director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER) will join the firm as a Principal on the Drug & Biological Products Team.
Donald D. Ashley, J.D., former Director of CDER’s Office of Compliance at the FDA, will join the firm’s Product Quality, Manufacturing, and Compliance Team as Executive Vice President.
The addition of Sandy and Don to the already extensive team of experts expands the firm’s unmatched regulatory expertise.
Learn more about Greenleaf’s growing team of respected professionals.
Greenleaf’s Drug Development Tool Services
Greenleaf’s experts provide strategic regulatory support for the development and regulatory use of drug development tools (DDTs), including biomarkers and novel technologies. In addition to critical assessment of a client’s goals, Greenleaf identifies regulatory and/or scientific gaps and recommends potential paths to address those gaps.
Learn more about Greenleaf’s DDT services
Greenleaf Offers Full Portfolio of Digital Health Services
Players in the digital health space face unique challenges in navigating an ever-changing regulatory landscape, as FDA regulators try to keep up with the pace of digital health technology development. Greenleaf serves as a trusted partner to both large and small clients developing and commercializing innovative digital health technologies as they navigate the complex landscape of FDA regulations and policies. Learn More
TEAM SPOTLIGHT: Mark Kramer – Former Head of FDA’s Office of Combo Products
Mark Kramer has joined the firm as Executive Vice President, Medical Devices and Combination Products.
Mark’s prior experience provides a unique perspective to his role as Executive Vice President, Medical Devices and Combination Products. In addition to serving as Director of the Office of Combination Products (OCP) , Mark was also responsible for establishing the office. In this role, Mark oversaw the development of significant regulations, policies, and practices currently in effect for combination products, including the primary mode of action rule, the cGMP rule, the adverse event reporting rule, numerous guidance documents clarifying the regulation of combination products, and the intercenter consultation process.
Learn more about Mark Kramer.
Greenleaf Expands Regulatory Policy Services
Greenleaf Health is pleased to announce that the firm has enhanced its existing regulatory policy services with a dedicated team and more extensive portfolio of capabilities. Designed to support the needs of large and small clients, Greenleaf’s regulatory policy services provide valuable expertise and guidance for clients as they encounter complex FDA regulatory policy challenges.
A dedicated Regulatory Policy Services Team will be guided by long-time Greenleaf team member, Kate Cook, who will assume a new leadership role at the firm as Principal, Regulatory Policy.
Greenleaf Expands Litigation Support Services
Greenleaf is expanding the firm’s litigation support capabilities to include an outside network of experienced and knowledgeable FDA experts adept at advising litigators representing FDA-regulated clients. The Greenleaf Litigation Support Services Network now provides litigators access to advisors with extensive, in-depth experience related to drug and biological products as well as medical devices and product quality, manufacturing, and compliance. Learn more
Strategically Planning Premarket Submissions for an Early-Stage Device Company
With the advantage of Greenleaf’s strategic advice and unique insight into the 510(k) process, the start-up was granted a de novo classification request and subsequent clearance of its second-generation device, paving the way to a successful U.S. launch.
Comprehensive Services
Greenleaf’s blend of subject expertise, strategic perspective, and FDA institutional knowledge enables us to provide reliable, objective guidance to clients as they encounter complex regulatory challenges. Our teams work cross-functionally to deliver comprehensive regulatory services in the following areas:
Drugs
Strategic advice on therapeutic product development, regulatory review, and postmarket requirements, as well as pipeline review and FDA milestone meeting preparation
Greenleaf Health
Greenleaf’s comprehensive services and wealth of experience ensure that clients can count on expert guidance as they navigate complex regulatory challenges.
Devices
Insight and guidance throughout the regulatory process for medical devices and combination products, including premarket strategic planning, submissions, and FDA meetings and engagement
Compliance
Full-service quality and compliance support, from on-site and remote compliance assessments, remediation, and inspection readiness to clinical quality systems and supply chain optimization
Cell & Gene Therapy
Specialized assistance with FDA interactions and submissions to support development, review, manufacturing, quality, and compliance for cell and gene therapies
Litigation Support Services
Expert opinions and FDA regulatory knowledge to support litigators and their clients in disputes related to medical devices, drug and biological products, and product quality, manufacturing, and compliance
Advisory Services
Regulatory risk assessments for life science investors — based on extensive research and due diligence, informed by Greenleaf’s deep regulatory knowledge
Regulatory Policy Services
Support for stakeholders in communicating effectively about FDA regulatory policy issues and in understanding, implementing, and complying with the FDA’s regulatory programs
Digital Health
Strategic guidance in navigating and complying with the complex landscape of FDA regulations and policies related to digital health technologies
Connect With Greenleaf
Greenleaf’s nationally recognized experts are continuously advancing the field of FDA regulatory policy and medical product development with original perspective and analysis. Access this insight and find out where they’re speaking and publishing next by following us on LinkedIn.