An Evolving Global Industry Requires a Dynamic Approach
The life sciences industry has increased its demand for more robust, harmonized quality systems and experienced talent who know the evolving regulatory requirements. With the continual evolution of national and international regulations, manufacturers face significant challenges to keep up and comply. The importance of compliance is not only to ensure a quality product. It’s also crucial because the cost of noncompliance is 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.
EVERSANA’s Quality Compliance Solution
EVERSANA’s Quality Compliance 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. With over 100 years of combined industry 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 within the medical device, pharmaceutical, tissue, donor eligibility, and other regulated spaces. 
Connectivity Across the Life Cycle
Through the integration of internal data, external data and real-world evidence (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.
Quality System Outsourcing
EVERSANA’s Quality System Outsourcing solutions have been implemented for hundreds of clients, which has helped them pass thousands of regulatory inspections over the past 20 years. Quality System solutions can be implemented in a phase-based approach to right size the Quality System for the Company and/or Product’s current lifecycle. Our Quality Systems solutions come compliant to the latest FDA and ISO requirements and can be customized to include requirements for any regulatory agency. These solutions include systems tailored for Medical Device, Pharmaceutical, Biologic, Tissue, and Combination Products.
Clients having an existing QMS, and looking to extend their product portfolio, or creating a Combination Product can also benefit from EVERSANA’s “Bolt-On” QMS. The “Bolt-On” QMS allows use of the current QMS while only adding (or “Bolting On”) elements required to satisfy the additional regulatory requirements.