Greenleaf Health
Greenleaf Health is a leading FDA regulatory consulting firm dedicated to providing strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies. As part of the ELIQUENT Life Sciences team, Greenleaf combines unmatched expertise and institutional knowledge to support clients navigating complex regulatory landscapes, including drug, device, biologics, cell and gene therapy, digital health, and cosmetics. The firm emphasizes collaboration, innovation, and a comprehensive approach to regulatory challenges, aiming to support global health through regulatory excellence.
Industries
Nr. of Employees
small (1-50)
Greenleaf Health
1055 Thomas Jefferson Street, NW, Suite 450, Washington, D.C. 20007
Services
Strategic regulatory advice and technical support throughout drug and biologic product development, regulatory review, and postmarket obligations.
Regulatory planning and submission support for medical devices and combination products, including premarket strategy, jurisdiction assessment, and agency engagement.
Full-service quality and compliance support including compliance assessments, remediation, inspection readiness, audits, and supply chain quality improvement.
Specialized assistance for cell and gene therapy development, manufacturing, quality systems, and regulatory submissions.
Regulatory risk assessments, due diligence for transactions, and investor-focused regulatory advisory services.
Policy analysis, stakeholder engagement, and strategic support for navigating and influencing regulatory policy and programs.
Strategic regulatory advice and technical support throughout drug and biologic product development, regulatory review, and postmarket obligations.
Regulatory planning and submission support for medical devices and combination products, including premarket strategy, jurisdiction assessment, and agency engagement.
Full-service quality and compliance support including compliance assessments, remediation, inspection readiness, audits, and supply chain quality improvement.
Specialized assistance for cell and gene therapy development, manufacturing, quality systems, and regulatory submissions.
Regulatory risk assessments, due diligence for transactions, and investor-focused regulatory advisory services.
Policy analysis, stakeholder engagement, and strategic support for navigating and influencing regulatory policy and programs.
Expertise Areas
- Regulatory compliance and enforcement
- Drug and biologic regulatory strategy
- Medical device and combination product regulation
- Quality management for advanced therapies
Key Technologies
- Real-world evidence (RWE) data platforms
- Biomarker qualification methodologies
- Clinical outcomes assessment methods
- Regulatory submission frameworks (IND/IDE/NDA/BLA/510(k)/PMA/EUA)
News & Updates
Greenleaf Health has expanded its compliance and manufacturing portfolio to include Good Clinical Practice (GCP) services, providing strategic and technical guidance for clinical trial quality systems.
Greenleaf is expanding its litigation support services to include a network of FDA experts to advise litigators on FDA regulatory issues and provide expert opinions.
John Jenkins, M.D., a 25-year FDA veteran, joins Greenleaf as Principal to lead the Drug and Biological Products team, bringing extensive experience in drug development and regulation.
Sandra Kweder, M.D., and Donald D. Ashley, J.D., former senior FDA officials, join Greenleaf to expand its regulatory expertise in drug and biologics.
Greenleaf has added GCP services to its portfolio, including assessments, mock inspections, and remediation, to support clients' clinical trial quality and compliance.
Greenleaf Health has expanded its compliance and manufacturing portfolio to include Good Clinical Practice (GCP) services, providing strategic and technical guidance for clinical trial quality systems.
Greenleaf is expanding its litigation support services to include a network of FDA experts to advise litigators on FDA regulatory issues and provide expert opinions.
John Jenkins, M.D., a 25-year FDA veteran, joins Greenleaf as Principal to lead the Drug and Biological Products team, bringing extensive experience in drug development and regulation.
Sandra Kweder, M.D., and Donald D. Ashley, J.D., former senior FDA officials, join Greenleaf to expand its regulatory expertise in drug and biologics.
Greenleaf has added GCP services to its portfolio, including assessments, mock inspections, and remediation, to support clients' clinical trial quality and compliance.