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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
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
Drug & Biological Products
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
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
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
Greenleaf Health
Greenleaf’s comprehensive services and wealth of experience ensure that clients can count on expert guidance as they navigate complex regulatory challenges.
Cosmetics
Regulatory strategy, policy guidance, and compliance services for consumer products marketed in the cosmetics space
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