Why Greenleaf?

Services at a Glance

With our comprehensive services and the wealth of knowledge available through our subject experts and network of technical specialists, clients can rely on unmatched guidance throughout the regulatory process.


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


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


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

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

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.

Greenleaf in Detail

To explore Greenleaf’s complete portfolio of capabilities and expert teams, view or download the PDFs below.