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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. 

Capture information on Greenleaf’s portfolio of services and cross-functional teams in one place.

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.

Advisory Services

Regulatory risk assessments for life science investors — based on extensive research and due diligence, informed by Greenleaf’s deep regulatory knowledge

Cell & Gene Therapy

Specialized assistance with FDA interactions and submissions to support development, review, manufacturing, quality, and compliance for cell and gene therapies

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

Devices

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

Drugs

Strategic advice on therapeutic product development, regulatory review, and postmarket requirements, as well as pipeline review and FDA milestone meeting preparation

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

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.

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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