Reducing Risk and Accelerating Clients’ New Technology
EVERSANA’s Quality Ccompliance provides a holistic lens across the product life cycle. Our team understands that an effective and efficient Quality System is critical to successfully launch a global product that meets all regulatory compliance regulations. The industry has increased its demand for more robust systems and experienced talent who know the evolving regulatory requirements because the costs of noncompliance are high: rejected product, delays to commercialization, product recall, product complaints, adverse events and/or agency action. Our Quality Compliance team is prepared for the challenge.
Experience Matters
With more than two decades of experience, our team brings an unrivaled level of expertise in quality and regulatory compliance consulting, Quality System outsourcing, quality management systems, document control and training management software and services, tissue services, and donor eligibility system software and services. For a complete view of our experience across these services, visit eversanaconsulting.com.
Reducing Risk and Accelerating Clients’ New Technology
Connectivity Across the Lifecycle
Through the integration of internal and external data and RWE combined with advanced analytics, our Quality Compliance team provides a predictive and proactive approach to insights that allows us to deliver continuous readiness models for regulatory inspections that are more cost efficient. The team is built with enhanced flexibility in mind and delivers ROI operational efficiencies, quality reputation and competitive advantages.
Extensive Portfolio of Offerings
Quality Compliance Excellence
- Quality Systems
- Quality Systems Software
- Design Control Execution Support
- Process Optimization, Verification and Validation
- Didactic Training Sessions
- Quality Strategy (Pharma/Biologics/Tissue/Medical Device/Combination products)
Regulatory Compliance/Auditing
- Gap Assessments
- Mock Audits/Inspections
- Due Diligence Assessments
- Inspection/Audit Management and Support
- Remediation
- General Auditing
