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.

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:

Greenleaf works with life science entities to evaluate and strengthen compliance functions with an eye toward optimizing processes, mitigating risks, and creating a culture of compliance, while continuing to meet business objectives.

Greenleaf and our network perform objective audits and produce, refine, and implement system-wide enhancements for strengthening:

  • Corporate quality systems
  • Corporate training programs
  • Corporate compliance designs
  • Corporate quality and compliance organization
  • Operational processes
  • Audit programs
  • Management systems (corporate-wide or individual facilities)
  • Strategic compliance and risk management

An FDA inspection is a significant moment for any regulated company. Greenleaf’s expert team and network strengthen clients’ readiness for FDA preapproval and surveillance inspections through consulting, training, audits, and mock inspections. 

We provide in-person and live video training for executives, managers, and staff on the following subjects:

  • FDA inspection authority
  • GCP inspection expectations
  • Inspection terminology and guidelines
  • Inspection process, roles, and responsibilities
  • Inspection and personnel management
  • Responses and remediation

We equip companies for inspection activities by:  

  • Setting proper expectations for an inspection 
  • Preparing data, documents, and records in advance to facilitate inspection efficiency
  • Conducting audits to identify potential areas of non-compliance or risks that require remediation
  • Mentoring and coaching participants before, during, or after an inspection to aid an efficient and accurate inspection

Our experts also enable preparedness and learning in a simulated inspection environment through mock FDA inspections that involve:  

  • Preparing and conducting mock inspections
  • Conducting gap analysis
  • Identifying and prioritizing deficiencies
  • Providing corrective action support
  • Providing guidance during inspection
  • Assisting with revision and preparation of all relevant documents

Greenleaf specialists bring an unmatched level of credibility and trust when interacting with the FDA and guiding companies along the remediation pathway. Our strategic and technical support includes:

  • Designing comprehensive remediation plans
  • Building and enabling corrective action plans (CAPs)
  • Supporting implementation of remediation actions
  • Providing objective review of and guidance on responses to enforcement actions
  • Third-party reporting of progress against improvement commitments
  • Auditing

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.

The experts in our compliance practice offer strategic insight and direction on:

  • FDA inspection, compliance, and enforcement procedures
  • FDA organization and structure as they relate to compliance functions and decisions
  • Impact of compliance-related legislation, regulations, and guidance
  • FDA trends and priorities

The team also develops and delivers training — both in-person and via live video — on a variety of regulatory subjects.

Greenleaf professionals understand the nuances of working with regulatory authorities and bring value to any communication with the FDA, including formal regulatory communication, in-person meetings, and responses to compliance actions. 

Our communication services encompass:

  • Readying clients for FDA meetings and facilitating effective interactions with the FDA
  • Providing guidance on FDA meeting requests and requisite briefing packages
  • Serving as a liaison for FDA meetings and correspondence
  • Assisting and representing clients in FDA communications and meetings
  • Supporting postinspection correspondence and meetings

Greenleaf’s experts also provide objective review of critical regulatory correspondence and recommendations for effective responses to:

  • FDA Form 483s
  • Warning letters
  • Untitled letters
  • Facility and supply chain audit reports
  • cGMP deficiency letters
  • Establishment inspection reports (EIRs)
  • Other compliance- and enforcement-related actions

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.

Our strategic services include gap analysis and recommendations for the following systems:

  • Risk-based quality management
  • Adverse Event Reporting Systems 
  • Corrective and preventive action (CAPA) plan design and processes
  • Clinical operations and monitoring
  • Clinical quality manuals
  • Electronic submissions
  • GCP protocols
  • Management review
  • SOP audits and document review
  • Vendor quality agreements

Greenleaf experts review and audit GCP documents, evaluate GCP compliance at clinical sites, and identify areas of conformance and nonconformance for external vendors.

Document Audits

  • Case reports
  • Clinical study reports
  • Final study reports
  • Informed consent statements
  • Protocols
  • Trial Master Files

Site Audits

  • Clinical Investigator Site Audits
  • Sponsor Audits
  • Laboratory Audits

Vendor Audits

  • Contract research organizations
  • Institutional Review Boards
  • Clinical trial suppliers
  • Drug depots
  • Vendor qualifications, including quality agreements with vendors

Greenleaf develops and delivers in-person and live video training on FDA regulations, policies, and procedures. Training of quality assurance and clinical research personnel covers:

  • Quality by Design clinical trials
  • Data integrity
  • Financial disclosures
  • GCP for sites and sponsors
  • International Conference on Harmonization (ICH) guidelines
  • Informed consent process
  • IRB and Human Subject Protection
  • Quality system requirements for research sites
  • FDA Bioresearch Monitoring Compliance Program Guides
  • GCP inspection expectations

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.

Learn more about Greenleaf’s Cell and Gene Therapy services

Combination Product Support Services

Greenleaf provides strategic advice throughout the combination product lifecycle, including review of and advice on company procedures to ensure compliance with regulatory requirements for combination products.

Learn more about Greenleaf Health’s Combination Product Support services

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.

Learn more about Greenleaf’s Digital Health services

Cosmetics Regulatory Services

Greenleaf works with clients to clarify and support compliance with the regulatory requirements for consumer products marketed in the cosmetics space.

Learn more about Greenleaf’s Cosmetics Regulatory services

Cannabis-Derived Product Services

Greenleaf offers expert regulatory consultation on all aspects of the FDA’s regulation of cannabis-derived products, including dietary supplements, cosmetics, foods, and other consumer products. Greenleaf specialists provide strategic and technical guidance on cannabis-derived product development, marketing, manufacturing, and compliance, with expertise in:

  • Regulatory risk assessment
  • Clarification of regulatory pathways and requirements
  • Product labeling and promotion
  • Product quality, manufacturing, and compliance
  • Compliance assessments, remediation, and inspection readiness
  • Regulatory policy consultation, strategic planning, and communications

Advisory Services

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.

Learn more about Greenleaf’s Advisory services

Success Stories

  • 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 …

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.

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