FTI Consulting Health Solutions

Regulatory Risk, Quality and Compliance Services

As we advance towards a post COVID-19 “New Normal”, forward-thinking life sciences companies recognize that Quality is a driver of business and supply chain resilience, top-line growth, improved profitability, and sustained regulatory compliance while, most importantly, providing higher quality and safe medical products.

Quality and Compliance Services

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

Quality Process Excellence — We help clients with the simplification and harmonization of quality processes (including enterprise-level) to reduce complexity, increase efficiencies/effectiveness, and improved margins while sustaining compliance.

Intelligent Automation — As the workforce is adjusted due to the impact of COVID-19, new ways of working will be explored. 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, time-consuming tasks and enhance quality processes.

Quality Management System (QMS) Optimization — We help our clients enhance and strengthen their QMS globally across key components including strategy, capabilities, governance, processes and technology. We help operationalize new and emerging regulations and enable adoption of new technologies.

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 that monitor performance, mitigate risk, and prevent quality problems. We help organizations to move "quality beyond compliance" and demonstrably enhance product quality and patient safety.