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.