What We Offer

An integrated solution that uses AI/ML technologies to track, consolidate, and catalogue information on regulatory requirements and their impact across markets, making the intelligence available across regulatory functions. The solution enables informed decision-making by providing recommendations on optimal route to regulatory approvals 

Who Is It For

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

Why It’s Important

Ensure regulatory intelligence across the organization

Comply with regulations across all operating markets

Automate change management with evolving regulations

How We Deliver

Process

NEXT Regulatory Intelligence solution uses an NLP-based crawler and data aggregator tool that gathers pertinent regulatory information from authenticated external and internal sources like regulator portals, health agency sites, journals, publications, trial registries, pink sheets, news releases, and more.

An AI-enabled recommendation engine analyzes the information, classifies and tags them for curation. It compares the information with similar past filing experience data and draws interpretations on deliverables impacted, and also sets precedents for future filing instances. 

The tool applies rules to categorize and classify intelligence and interpretations for business.

What Makes Us Different

AI/ML technologies to gather, maintain, catalogue, and distribute regulatory information

Seamless integration with downstream dossier submission planning engines

Inbuilt dossier templates from all majority market regions

Case Study