Expanded Quality & Compliance Services
The FDA’s continued emphasis on proactive quality management and cGMP compliance presents new challenges and opportunities for the private sector, making it essential for companies to build quality, safety, and integrity into their products.
Recognizing this, Greenleaf offers an enhanced portfolio of services that includes comprehensive on-site compliance assessments, remediation, and inspection readiness. When added to Greenleaf’s core regulatory consulting services, this expanded compliance support ensures a full-service experience for companies navigating today’s evolving regulatory environment.
Greenleaf’s strategic capacity encompasses the following:
- Inspection Readiness: Strengthen clients’ readiness for FDA preapproval and surveillance inspections through consulting, training, audits, and mock inspections
- Compliance Assessments: Perform objective audits and evaluations of clients’ operations to identify strengths and areas in need of improvement
- Compliance Remediation: Develop strategy and support implementation of clients’ remediation plans and responses to enforcement actions
- Good Clinical Practice (GCP): Strategic and technical expertise to strengthen quality management systems and guide companies developing and improving clinical quality systems
To further enhance the firm’s robust compliance services, Greenleaf has developed an Independent Contractor (IC) Network of additional technical experts who can be deployed to provide on-site services at entities that manufacture FDA-regulated products.
To learn more about Greenleaf’s network of technical experts and the services they provide, visit Greenleaf’s IC Network.
STRATEGIC & TECHNICAL CAPABILITIES
Greenleaf is committed to serving our clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports the availability of safe, effective, and high-quality drugs, biologics, and devices.
Greenleaf’s Product Quality, Manufacturing, and Compliance Team has a proven track record of achieving success. Practice experts specialize in corporate quality and compliance systems; FDA inspections, compliance, and enforcement processes; FDA organization and structure as they relate to compliance functions and decisions; FDA communications, including enforcement letters and facility and supply chain audit reports; and the complete spectrum of compliance- and enforcement-related actions. Members of the Greenleaf team work cross-functionally, combining their depth of knowledge and breadth of expertise to guide companies through challenging quality, compliance, and regulatory matters.
Greenleaf’s compliance services are recognized as best in class by companies seeking strategic and technical expertise to strengthen their quality management and compliance systems. To learn more about Greenleaf’s compliance services, click here.
GREENLEAF'S COMPLIANCE SERVICES
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 experts conduct 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
CONSULTATION & REGULATORY GUIDANCE
The Greenleaf team partners with companies to deliver strategic and technical guidance that helps achieve business and regulatory objectives.
Greenleaf provides corporate insight and direction on the following:
- 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
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.
Greenleaf provides the following FDA communication services:
- Readying clients for FDA meetings and facilitating effective interactions with the FDA
- Providing guidance on FDA meeting requests and requisite briefing packages
- Serving as liaison for FDA meetings and correspondence
- Assisting and representing clients in FDA communications and meetings
- Supporting postinspection correspondence and meetings
Greenleaf also delivers analysis and response recommendations for:
- 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
An FDA inspection is a significant moment for any regulated company. Greenleaf experts strengthen clients’ readiness for FDA preapproval and surveillance inspections through consulting, training, audits, and mock inspections.
Greenleaf’s inspection readiness services train executives, managers, and staff in advance of an FDA inspection.
- FDA inspection authority
- GCP inspection expectations
- Inspection terminology and guidelines
- Inspection process, roles, and responsibilities
- Inspection and personnel management
- Responses and remediation
Greenleaf helps equip companies for inspection activities by providing the following services:
- Setting proper expectations for an inspection
- Prepare 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 of participants before, during, or after an inspection to aid an efficient and accurate inspection
Greenleaf experts also enable preparedness and learning in a simulated inspection environment by conducting mock FDA inspections.
- Prepare and conduct mock inspections
- Conduct gap analysis
- Identify and prioritize deficiencies
- Provide corrective action support
- Provide guidance during inspection
- Assist 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.
Greenleaf’s remediation services include:
- Designing comprehensive remediation plans
- Building and enabling corrective action plans (CAPs)
- Supporting enforcement of remediation actions
- Third-party reporting of progress against improvement commitments
Greenleaf understands the complex environment within which life science transactions take place and frequently advises investors to evaluate potential issues and regulatory risks that may be identified during such transactions.
Greenleaf’s advisory services include research and analysis of the following potential sources of risk:
- Marketing authorization
- Manufacturing and quality issues
- Distribution and supply chain
- Pipeline review
- Compliance status
- Product safety
CLINICAL QUALITY SYSTEMS
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.
- Case reports
- Clinical study reports
- Final study reports
- Informed consent statements
- Trial Master Files
- Clinical Investigator Site Audits
- Sponsor Audits
- Laboratory Audits
- Contract research organizations
- Institutional Review Boards
- Clinical trial suppliers
- Drug depots
- Vendor qualifications, including quality agreements with vendors
Greenleaf routinely develops and delivers training on FDA regulations, policies, and procedures. Training of quality assurance and clinical research personnel includes the following subjects:
- 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