Regulatory, Quality and Compliance Services

Forward-thinking life sciences companies recognize that Quality is a driver of top-line growth, improved profitability, and sustained regulatory compliance while, most importantly, providing higher quality, safer medical products.

Quality and Compliance Services

Product Quality Strategy – We assist with the development and execution of strategies that shift focus from compliance to continuous improvement, fueling innovation and growth, operational effectiveness, profitability, and a culture of quality.

Quality Management System (QMS) Optimization – We perform capability maturity and risk assessments and work with clients to enhance and strengthen their QMS globally across key components including strategy, capabilities, governance, processes and technology. We help operationalize emerging regulations and enable adoption of new technologies.

Quality Process Excellence – We facilitate simplification, harmonization and automation of quality processes to reduce complexity, increase efficiency and effectiveness, and improve margins while sustaining compliance.

Intelligent Automation – We assist clients with leveraging new technologies including robotic process automation (RPA), machine learning (ML), natural language processing (NLP), and advanced analytics to automate repetitive tasks as well as accelerate continuous improvement.

Regulatory Compliance Remediation – We assist our clients in responding to regulatory enforcement including the development and execution of corrective action plans. We improve processes, not only to address identified problems but to enable operational efficiency and sustained compliance.

Quality and Risk Analytics – Utilizing cutting-edge analytical techniques, we help companies develop capabilities and dashboards that monitor performance, mitigate risk, and prevent quality problems. We help organizations to achieve "quality beyond compliance" and demonstrably enhance product quality and patient safety.

Culture of Quality/Change Management – We develop and execute change management plans to transform companies from a Culture of Compliance (Doing things right) to a Culture of Quality (Doing the right things).