Expanded Quality & Compliance Services
The FDA’s continued emphasis on proactive quality management and CGMP compliance presents new challenges and opportunities for the life science industry, making it essential for companies to build quality, safety, and integrity into their products.
Recognizing this, Greenleaf has expanded the firm’s portfolio of services to include comprehensive on-site compliance assessments, remediation, and inspection readiness. By expanding Greenleaf’s core regulatory consulting services, the firm is now capable of providing a full-service experience for companies navigating today’s evolving regulatory environment.
Greenleaf’s expanded strategic capacity and capabilities include the following comprehensive quality, compliance, and manufacturing services:
- Inspection Readiness: Strengthen clients’ readiness for FDA pre-approval and surveillance inspections through consulting, training, audits, and mock inspections.
- Compliance Assessments: Perform objective audits and assessments of a clients’ operations to identify strengths and areas of needed improvements.
- Compliance Remediation: Develop strategy and support implementation of clients’ remediation plans and responses to enforcement actions.
To further enhance the firm’s robust compliance services, Greenleaf has developed an Independent Contractor (IC) Network comprised of additional technical experts capable of being deployed to provide on-site services at firms that manufacture FDA-regulated products.
To learn more about Greenleaf’s expanded services and network of technical experts, visit Greenleaf’s IC Network.
STRATEGIC & TECHNICAL CAPABILITIES
Greenleaf is committed to serving 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. Members of the Greenleaf team work cross-functionally to combine 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 systems and guide them through the challenging FDA regulatory landscape.
GREENLEAF'S COMPLIANCE SERVICES: FAQ
Greenleaf works with businesses to evaluate and strengthen corporate compliance functions with an eye towards optimizing processes, mitigating risks, and creating a culture of compliance, while continuing to meet business objectives.
Greenleaf experts conduct audits and develop, refine, and implement system-wide improvements for strengthening:
- Corporate quality systems
- Corporate training programs
- Corporate compliance strategies
- 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 critical moment for any regulated company. Greenleaf experts strengthen clients’ readiness for FDA pre-approval and surveillance inspections through consulting, training, audits, and mock inspections.
Greenleaf experts help prepare companies for inspection activities by:
- Training executives, managers, and staff on setting proper expectations for an inspection and helping to 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
- Conducting mock inspections to enable preparedness and learning in a simulated inspection environment
- Mentoring and coaching of participants, before, during or after an inspection, to support an efficient and accurate inspection
CONSULTATION, TRAINING & REGULATORY GUIDANCE
Members of the Greenleaf team partner with companies to deliver insight and guidance that helps achieve their business and regulatory objectives. The Greenleaf team also develops and delivers training in a variety of regulatory areas.
Greenleaf provides corporate insight and guidance on the following:
- FDA inspection, compliance, and enforcement processes
- 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 also routinely develops and delivers training on subjects including:
- Agency regulations, policies, and procedures
- GxP requirements, quality system regulation compliance and other compliance-related issues
- Preparing for FDA inspections and meetings
- Facilitating effective interactions with FDA
- Issuing technical reports, determining policies and procedures, and revising company SOPs
Greenleaf’s team of experts 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:
- Prepare for FDA meetings and facilitating effective interactions with the FDA
- Prepare FDA meeting requests and requisite briefing packages
- Serve as liaison for FDA meetings and correspondence
- Assist and represent clients in FDA communications and meetings
- Support post-inspection correspondence and meetings
Greenleaf also provides 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
Greenleaf experts bring an unmatched level of credibility and trust when interacting with the FDA. The Greenleaf Compliance Team has the experience and insight to successfully guide companies along the remediation pathway.
Greenleaf’s remediation services include:
- Development of comprehensive remediation strategies
- Develop and implement corrective action plans (CAPA)
- Support implementation of remediation strategies
- 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 life sciences 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 Analysis
- Compliance Status
- Product Safety