NEXT Regulatory Intelligence
Simplify consolidation of regulatory market rules, requirements, and precedence
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
Resources
