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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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
Cosmetics
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.
Helping a Digital Therapeutic Client Successfully Navigate the De Novo Regulatory Pathway
With Greenleaf’s guidance, the client was able to resolve all outstanding review issues, resulting in the FDA’s decision to grant their de novo request.
Assessing Systemic Compliance Concerns to Fulfill FDA and Corporate Objectives
In response to an FDA warning letter, Greenleaf performed an independent retrospective assessment of the client’s GMP investigations and systems and presented findings and actionable recommendations that were accepted by the FDA and positioned the company to implement CAPAs.
Leading a Client Through Dispute Resolution to Product Approval
When a CRL threatened a company’s lead product, Greenleaf helped initiate a successful dispute resolution request and revise the submission in order to gain approval.
Achieving a Breakthrough Device Designation
By working with Greenleaf throughout the breakthrough request process, a multinational device company was able to differentiate their technology and productively interact with the FDA to secure breakthrough designation.
Conducting Due Diligence to Guide a Corporate Acquisition Decision
When a major investment firm was weighing the acquisition of a medical device company, Greenleaf’s Advisory Services Team performed a regulatory risk assessment of the target company’s compliance and promotional materials that furnished the confidence needed to proceed.
Enabling Expansion Into Cell and Gene Therapy Manufacturing
Equipped with a comprehensive strategic evaluation and ongoing support from Greenleaf’s experts, the company was able to develop and implement QMS improvements supporting new manufacturing practices for cell and gene therapy products.
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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