Product Quality, Manufacturing & Compliance
The FDA’s continued emphasis on proactive quality management and cGMP compliance makes it essential for companies to build quality, safety, and integrity into their products.
Recognizing this, Greenleaf offers a complete portfolio of services that includes comprehensive on-site compliance assessments, remediation, and inspection readiness, in addition to our core regulatory consulting services, ensuring full-service quality and compliance support for companies navigating the complex global manufacturing environment.
Quality & Compliance Team
Greenleaf’s Product Quality, Manufacturing, and Compliance Team provides services that are recognized as best in class by companies seeking to strengthen their quality management and compliance systems.
John TaylorPresident and Principal, Compliance and Regulatory Affairs
Cynthia SchnedarPrincipal, Regulatory Compliance
David ElderPrincipal, Regulatory Compliance
Kalah Auchincloss, J.D., M.P.H.Executive Vice President, Regulatory Compliance and Deputy General Counsel
Kristen C. GrumetSenior Vice President, Regulatory Compliance
Grace E. McNallySenior Vice President, Regulatory Compliance
Elizabeth OestreichSenior Vice President, Regulatory Compliance
Thomas R. Berry, Pharm.D.Senior Vice President, Regulatory Compliance
Dawn WydnerSenior Vice President, Regulatory Compliance
Maria BonnerVice President, Regulatory Compliance and Deputy General Counsel
Madeleine Giaquinto, J.D.Director, Regulatory Affairs
Brittany MilbyExecutive Director of Operations, Regulatory Compliance
Laura BarteeExecutive Director of Operations, Regulatory Compliance
Our Quality and Compliance Services
Compliance Assessments, Inspection Readiness, and Remediation
Greenleaf’s in-depth understanding of the FDA and global compliance experience give clients the strategic and technical support needed to align their approach with the FDA’s quality, safety, and compliance expectations. Greenleaf also engages a network of independent contractors who provide specialized technical expertise, both on site and remotely. Our capabilities include:
Remote Compliance Services
While companies face the complexities of navigating today’s challenging public health landscape, Greenleaf and our network of independent compliance experts are prepared to assist clients with remote quality and compliance services, including:
- Procedural and record review
- Data and trending review
- Corrective action assessment
- Regulatory response support
- Issue-specific information assessment and feedback
- Training via live video
Regulatory Programs and Communications
Greenleaf delivers insight and guidance that help clients achieve business and regulatory objectives.
Good Clinical Practices (GCP)
Greenleaf’s team of highly experienced specialists uses a risk-based methodology to develop and improve clinical quality systems. Because there is no one-size-fits-all approach to GCP compliance, each solution is built to fit the targeted needs of the client.
Supply Chain Optimization
Greenleaf consultants use a systemic approach to help clients strengthen and safeguard the integrity of their supply chain management practices, including:
- Evaluation and optimization of good supply practices
- Review and audit of good manufacturing, good distribution, good import/export, and product security practices
- Regulatory guidance on compliance with requirements of the Drug Supply Chain Security Act
- Guidance to successfully address compliance issues and potential or actual supply chain breaches
Cell and Gene Therapy
For developers of cell and gene therapies, Greenleaf experts provide strategic and technical support for establishing manufacturing and quality controls; pre- and postapproval inspection readiness; compliance assessments; evaluating and responding to FDA regulatory correspondence; and engaging with CBER’s Advanced Technologies Team.
Digital Health Services
Greenleaf experts provide guidance to clients developing, commercializing, utilizing, and investing in innovative digital health technologies as they navigate the evolving landscape of FDA digital health requirements.
Experts from Greenleaf’s Product Quality, Manufacturing, and Compliance Team provide advisory services that include extensive research and due diligence for investors engaged in potential deals that require regulatory risk analyses before and after decisions and transactions.
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 …
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; …
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 …
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 …
Developing a Regulatory Strategy to Successfully Manage Assessment and Conduct of a Large Phase 3 Program
Greenleaf Health assisted a mid-sized pharmaceutical company in developing a regulatory strategy to address safety and trial conduct issues in the phase 3 program for their lead compound for cardiovascular disease. During phase 3 trials, the client identified a consequential safety event and sought Greenleaf’s guidance on both addressing the safety event in the context …
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 …
Quality & Compliance Resources
View or download the PDFs below to learn more about Greenleaf and our quality and compliance capabilities.
Greenleaf’s Independent Contractor (IC) Network
To extend the firm’s robust compliance capabilities, Greenleaf has developed an Independent Contractor (IC) Network of additional specialized technical experts who can be deployed to provide comprehensive on-site compliance assessments, remediation, and inspection readiness at facilities manufacturing FDA-regulated products.
Greenleaf and our network also provide remote services to support clients’ quality and compliance needs in the increasingly challenging global public health environment.
Join Our Network
Greenleaf welcomes former FDA officials and individuals with 15+ years of quality, manufacturing, and auditing operations experience in the pharmaceutical, biological drug, and/or medical device sectors.
When engaged through the Greenleaf IC Network, independent contractors are part of an elite team of experts alongside the Greenleaf Compliance Team. Working on projects with Greenleaf offers three distinct benefits: fulfilling work that promotes the advancement and protection of public health; strategically planned and managed projects directed and supported by Greenleaf’s executives; and competitive and prompt pay for services.
Interested applicants should visit Greenleaf’s IC Network Portal to complete the intake questionnaire and submit relevant professional documents. There is no deadline for submission; applicants will be considered for projects on an ongoing basis.