Pharmacovigilance and Regulatory Affairs

Accelerate the drug approval process and improve safety for patients by taking advantage of powerful technology and our deep safety and regulatory expertise.


Challenges we solve

Defining operating models for safety and regulatory

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.

Accelerating regulatory submissions

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

Safety and regulatory control tower

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.

Signal management to improve patient safety

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


ZS’s approach

ZS believes in the powerful combination of expertise and technology. We can help you innovate, analyze, predict and visualize to create the most advanced regulatory and pharmacovigilance practices.

Advisory solutions

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.

Data fabric

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.

Reporting and analytics

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

Content authoring automation

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.

Regulatory intelligence and health authority interaction solutions

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.

Safety insights

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.

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