PharmaSmart - Regulatory Intelligence AI Agent by HCLTech

Most Pharma companies scan hundreds of regulatory sites and sub sites (such as fda.gov) manually to review the regulatory changes and impact to their portfolio of drugs which can be effort and time intensive leading to delay in compliance and escalated cost.

The PharmaSmart - Regulatory Intelligence AI Agent solution offers following capabilities to expedite compliance to new regulations with lower effort.

• Crawl large number of regulatory websites and sub sites at pre-defined interval • Summarize the content of the websites • Generate a comprehensive report on the changes and sending at pre-defined interval to key stakeholders • Store the crawled content and enable further Q and A through a conversational Chabot • Full traceability on the sites crawled and report generation • Integration with existing RIM solutions

Solution architecture details:

• Crawler Agent is able to crawler different regulatory websites such as fda.gov, EMA etc. and retrieve the data • Summarizer Agent - Summarizes the crawled data and generates a comprehensive report compliance and impact report • Q and A Agent – Chabot using API Gateway, AWS Lambda and Bedrock Knowledge Bases can be used further Q and A based on crawled data • Email Notification Agent – Send a weekly report to Regulatory Intelligence team within organization • Integration Agent – Integrate the Agent with existing Regulatory Intelligence platform

Benefits:

• 70% manual effort reduction in crawling, summarizing and generating reports • Cost savings upto 70% • Highly extensible solution with ability to scale to any number of websites and sub sites, languages etc.