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 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): Design and improve clinical quality systems using a risk-based methodology tailored to clients’ needs
- Supply Chain Optimization: Evaluate and strengthen clients’ supply chain management practices to safeguard supply chain integrity and ensure compliance with regulatory requirements
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.
Learn more about Greenleaf’s compliance services: