A global environment governed by rigorous regulatory and safety requirements brings complexity. And having to understand and manage local regulatory requirements presents a significant burden. Few companies are able to fully maintain a current global regulatory intelligence database, and few have the infrastructure to handle rapid increases in safety-related activities and risk management. By aligning all aspects of marketed product maintenance, including regulatory, safety and benefit-risk management, you can improve compliance while reducing complexity and cost.

With the Quintiles Regulatory and Safety Optimization Solution, you partner with our experts to assess the value, strategy and key activities required to integrate regulatory, safety and benefit-risk management (BRM) capabilities. Our regulatory and safety experts perform a detailed diagnostic, including assessments of portfolio, operational capabilities and financial impact, to develop a solution. We create a roadmap to align your strategy, based on product, functional and regional priorities, and then help you achieve it – to reduce complexity, improve compliance and minimize costs.

Our Thinking

The hidden risks of mHealth apps