Quality and Compliance
Strategy | Development | Deployment and Management
We help our clients navigate complex and rapidly changing regulations and requirements by assisting in the interpretation of regulations, developing compliant processes and implementing controls and governance mechanisms to ensure continued compliance. We support our clients throughout the CAPA lifecycle.
Quality Management System
- Design, definition and implementation of governance organizations, quality management systems and processes to support compliance initiatives
- Development of Quality System Manual and business processes and procedures for the establishment of the Quality Management System
- Design of QMS and “Day One” procedures
SOP Strategy Development, Authoring, Deployment and Management
- Development of the strategy for the architecture and content of SOPs for operation and maintenance of R&D systems, e.g., document management systems, product information and registration tracking systems, regulatory information management systems
- Development of functional and cross-functional business processes, procedures and operating manuals followed by implementation and roll-out to key stakeholders and practitioners
Compliance Remediation Strategy Development and Support
- Design and execution of process and organizational risk assessments to identify and prioritize compliance risks, gaps and opportunities for improvement
- Development and implementation of business processes as part of CAPAs, risk reduction and compliance remediation activities
- Coordination of cross-functional leadership team activities for inspection readiness
- Development and successful implementation of remediation and revalidation plans for computer systems and data centers
cGxP Assessment, Training and Support
- Development and deployment of cGXP business processes
Commercial Compliance Business Process Optimization
- Implementation of a new business process across the Commercial, Medical, Legal and Regulatory departments to effectively manage the internal review and approval of advertising and promotional materials
- Deployment of a new process and associated management system to track the processing and approvals of all grant, donation and sponsorship requests globally
- Development of a single global process and platform to better manage cross-border engagements with Individual Service / Health Care Providers, ensure consistency, reduce manual processes and improve compliance
