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.
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
“Despite global disruptions in surveillance inspections and other regulatory operations, Greenleaf’s work on behalf of our clients continues.”
President, Greenleaf Health and Principal, Compliance & Regulatory Affairs
Led the FDA’s policymaking for global compliance and enforcement, providing direction to 4,000+ staff across more than 90 countries
Formulating a Regulatory Strategy to Successfully Manage Phase 3 Trial Issues
When safety and GCP concerns arose during a large phase 3 trial, Greenleaf helped the sponsor proactively address the issues with the FDA and preserve the integrity and momentum of their program.
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.
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:
Strategic advice on therapeutic product development, regulatory review, and postmarket requirements, as well as pipeline review and FDA milestone meeting preparation
Insight and guidance throughout the regulatory process for medical devices and combination products, including premarket strategic planning, submissions, and FDA meetings and engagement
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
Specialized assistance with FDA interactions and submissions to support development, review, manufacturing, quality, and compliance for cell and gene therapies
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
Regulatory risk assessments for life science investors — based on extensive research and due diligence, informed by Greenleaf’s deep regulatory knowledge
Greenleaf’s regulatory policy services assist stakeholders in communicating effectively about FDA regulatory policy issues and in understanding, implementing, and complying with the FDA’s regulatory programs.
Greenleaf Health 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.
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.