Resources and News

Access insights from the foremost FDA regulatory experts.

Read about how Greenleaf has applied our expertise to help clients achieve success in a variety of challenging regulatory scenarios. 

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Stay up to date with Greenleaf’s events, announcements, and news.

Capabilities and Services Downloads

Learn how the extensive capabilities of Greenleaf’s expert teams can support your company’s various regulatory needs by downloading our capabilities presentations. For a detailed description of our services and the value they deliver to clients, download the service-specific information sheets.

Drug & Biological Products

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 & Combination Products

Insight and guidance throughout the regulatory process for medical devices and combination products, including premarket strategic planning, submissions, and FDA meetings and engagement

Quality & 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

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

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

Litigation Support

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 strategy, policy guidance, and compliance services for consumer products marketed in the cosmetics space

Learn how Greenleaf works with clients to devise effective solutions to their most complex regulatory challenges. 

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.

Greenleaf News & Updates

Find Greenleaf’s current and past announcements about our firm, new and expanded services, and additions to our ever-growing team of experts.

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