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.

Trusted Perspective.
Unmatched Expertise.

Greenleaf’s experts have shaped the landscape of FDA regulatory policy and strategy for decades. We bring this unrivaled knowledge and unique insight to our work with clients every day.

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

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

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.

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.

Let’s Work Together

Greenleaf is dedicated to supporting life science companies with the highest quality of regulatory advice and insight. Please contact us to discuss your needs. We welcome the opportunity to work together toward your regulatory success.

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