Our Services

Greenleaf’s comprehensive services and wealth of experience ensure that clients can count on expert guidance as they navigate complex regulatory challenges. Our specialized teams work cross-functionally to provide a full-service engagement, with targeted regulatory capabilities in the following areas:

Drug & Biological Products

Greenleaf’s Drug and Biological Products Team specializes in providing strategic and technical guidance on medical product development, regulatory review, and postmarket requirements.

Strategic Regulatory Guidance

Consultation on scientific and regulatory practices for clinical programs and pre- and postmarket regulatory submissions and interactions

Pipeline Review

Pipeline evaluation and strategic advice to manage regulatory risk and guide planning decisions

Regulatory Policy

Strategic regulatory policy insight to support participation in and compliance with FDA programs and improve patient access to innovative products

Cell & Gene Therapy

Advice on regulatory requirements and development approaches, FDA interactions, and rare disease trial design

Medical Devices & Combination Products

Greenleaf’s Medical Device and Combination Products Team guides clients through the complete regulatory process, from early-stage development to marketing authorization and throughout the product lifecycle.

Strategic Regulatory Guidance

Strategic guidance and insight on all aspects of FDA regulatory programs, policies, and procedures

Premarket Review Process

Scientific and regulatory strategies for clinical programs and regulatory submissions

Combination Product Support Services

Guidance on combination product development, designation, submissions, and compliance

Litigation Support

Knowledge-sharing and expert witness services for litigators representing FDA-regulated companies

Product Quality, Manufacturing & Compliance

Greenleaf’s Product Quality, Manufacturing, and Compliance Team identifies and promotes practices that will align a client’s approach with the FDA’s quality, safety, and compliance expectations.

Strategic Regulatory Guidance

Insight and guidance on the FDA’s compliance processes, policies, and activities to help companies achieve business and regulatory objectives

Audits, Training, and Remediation

On-site and remote compliance assessments, remediation support, inspection readiness services, and training

Good Clinical Practices

Evaluation of clinical quality systems and risk-based recommendations for strengthening GCP

Supply Chain

Evaluation and optimization of supply chain management practices to strengthen and safeguard supply chain integrity and comply with regulatory requirements

Cell & Gene Therapy

Greenleaf assists sponsors of cell and gene therapies by optimizing FDA interactions and submissions to support development, manufacturing, quality, and regulatory review.

Advisory Services

Greenleaf understands the complex environment within which life sciences transactions take place and performs in-depth regulatory risk assessments tailored to investors’ needs.

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.

Digital Health Services

Greenleaf serves as a trusted partner to both large and small clients developing and commercializing innovative digital health technologies as they navigate the complex landscape of FDA regulations and policies.

Cosmetics Regulatory Services

Greenleaf works with clients to clarify and support compliance with the regulatory requirements for consumer products marketed in the cosmetics space.

Litigation Support Services

Greenleaf and our network of experts work closely with litigators representing FDA-regulated clients in an array of disputes related to medical devices, drug and biological products, and product quality and compliance.

Greenleaf in Detail

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

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.