What we offer

An intelligent regulatory submissions planning engine that applies AI and predictive analytics on regulatory submission timelines and historical submissions data to continuously learn and generate optimal submission plans

Who is it for

Heads of global regulatory affairs strategy, submissions planning, and global regulatory operations teams 

Why it’s important

Reduce cost and brand implications of non-compliance

Seamlessly manage submissions across markets

Optimize efforts through submission bundling and grouping

How we deliver


NEXT Regulatory Submissions Planning extensively uses AI and predictive analytics to centrally track regulations and plan for submissions across the globe, in real-time.

The tool predicts impact of new regulatory changes on submission timelines, helps to dynamically plan and prioritize submissions, and plan capacities to optimize internal employee workload. 

The AI-enabled recommendation engine identifies common documents that HAs require, recommends bundling and grouping opportunities for submissions to reduce effort duplication and ensure timely regulatory submissions.

What makes us different

Use of AI and predictive analytics to drive the process

Interactive graphical interface to plan submissions

Dashboards to analyze timelines and prioritize tasks

Markets covered across the globe
Effort savings for regulatory submission planning across markets
Years of healthcare industry experience

Case study