Success Stories

Learn how Greenleaf works with clients to devise effective solutions to their most complex regulatory challenges.

Evaluation & Development of a Cell and Gene Therapy Quality Management System

A biopharmaceutical company well-versed in small molecule manufacturing processes requested Greenleaf’s support in building out its cell and gene therapy (CGT) manufacturing facility processes. Specifically, Greenleaf was asked to assist in developing the company’s Quality Management System (QMS) for new modalities in order to understand its positioning for sustainability and expansion of operations.  Greenleaf experts …

Retrospective Assessment of Systemic Compliance Concerns

In response to an FDA warning letter request, a multinational pharmaceutical company selected Greenleaf Health as an independent third-party expert to perform retrospective assessment of out-of-specification (OOS) investigations and a systemic assessment of systems for investigations. Greenleaf experts developed a protocol for performing the retrospective review, which established the conclusiveness of OOS investigative results, determined …

Evaluating Systemic Manufacturing Compliance and Identifying Actionable Quality Recommendations

Following a string of what appeared to be isolated enforcement actions, a multinational pharmaceutical and medical device company requested Greenleaf’s assistance in evaluating the company’s manufacturing network for systemic compliance concerns. Greenleaf experts performed audits at 20 different locations in the United States and in six European countries. Two-person baseline audit teams, consisting of experts …

Medical Device Auditing and Certification for Compliance with FDA Guidelines

Greenleaf was selected by a multinational medical device company to serve as an independent GMP and Medical Device Reporting (MDR) expert. In this role, Greenleaf was made responsible for performing initial audits and procedural reviews at the company’s locations in the U.S. and Asia. Greenleaf’s work started with a review of company policies and procedures; …

Contributing a Chapter on In Vitro Diagnostics to an FDLI Book Publication

Greenleaf Health was invited by a partner at a prominent D.C. law firm to write a chapter on in vitro diagnostics (IVDs) for inclusion in a book to be published by the Food and Drug Law Institute (FDLI). In vitro diagnostics have become an increasingly large part of Greenleaf’s portfolio of regulatory services, furthered by …

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 …

Providing Litigation Support That Led to a Favorable Judgment for a Device Start-Up Firm

A medical device start-up was involved in a commercial dispute against a large multinational device manufacturer and sought Greenleaf Health’s services as an expert witness and consultant on the FDA regulatory grounds for the case. Greenleaf’s litigation support team prepared an expert report that reinforced the client’s arguments regarding the likelihood that the FDA would …

Collaborating to Streamline Review of a Complex PMA Submission

Greenleaf Health worked with a major orthopedic company to gain marketing authorization for a new formulation of an approved bone augmentation product. Due to the complex regulatory and scientific nature of this project, Greenleaf coordinated with a large team of in-house and external regulatory and scientific experts in order to devise the most advantageous strategy …

Planning and Supporting a Regulatory Strategy for De Novo and 510(k) Submissions

Greenleaf Health provided strategic and tactical advice to an early-stage start-up regarding their premarket submissions for a novel wound retraction system after the FDA determined that the company would need to follow the de novo pathway. The Greenleaf team assisted the company with development and submission of a de novo classification request for their product. …

Achieving a Breakthrough Device Designation

Greenleaf Health worked with a multinational medical device company throughout the review and submission of a breakthrough device designation request for a device indicated for the minimally invasive treatment of lung tumors. The Greenleaf team provided strategic advice on how to frame the device description and indication for the breakthrough request in light of the …

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