Product Quality, Manufacturing & Compliance

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

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

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