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  • Conducting Due Diligence to Guide a Corporate Acquisition Decision

    Greenleaf Health was engaged by a global medical device company to assist in conducting due diligence for the potential acquisition of another device company. Greenleaf’s Advisory Services Team evaluated the target company’s FDA compliance history and regulatory status, as well as their promotional and advertising materials, in order to assess the regulatory risk that would …

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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

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

Drugs

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

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.

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