Pharmacovigilance and Regulatory Affairs

As life sciences companies seek efficient operating models, it’s important to build a solid foundation for execution and provide leaders and teams with clear direction.

Our unique regulatory intelligence and health authority query (HAQ) management offerings, paralleled with content automation capabilities, help accelerate regulatory submissions.

With so many projects in your safety and regulatory practice, how can you track progress and flag risks? Safety and regulatory practice-specific dashboards can identify opportunities for organizing projects.

From safety signals management to predictive pharmacovigilance, it’s critical to truly innovate and deliver the best quality of care to patients.

From defining the most efficient organizational structure to designing a technology roadmap for the next five years, our advisory solutions will take your regulatory and pharmacovigilance organizations to the next level.

A critical first step to attaining powerful analytics is having the necessary data. We’ll help you build best-in-class data management infrastructure by considering business goals, analytical maturity, data access and current capabilities.

We can help create the analytics dashboards you need, while providing report development services backed by artificial intelligence (AI) and machine learning (ML).

Report authoring is time and effort intensive, due to the necessary manual information extraction from different sources. We can help save time by automating tedious portions of the regulatory content authoring process.

Our regulatory intelligence and HAQ solutions tap into historical data, inform data-driven regulatory decision-making and enable insights for rapid and efficient regulatory approvals.

It’s challenging to generate powerful safety insights. We use AI and ML algorithms to leverage historical data from similar studies, which can help generate impactful safety insights that enhance patient safety.