Finding the Needle: The challenges – and some solutions – of effective Regulatory Intelligence in Pharma

ABSTRACT

In today’s increasingly digitized regulatory landscape, Regulatory Intelligence (RI) is no longer about merely retrieving information—it’s about identifying the right information at the right time to ensure global compliance and informed decision-making. With over 3 million regulatory documents and publications available across major databases like PubMed, EMA, and FDA, RI professionals face the daunting task of navigating a vast, time-sensitive, and complex ecosystem of data.

This whitepaper explores the evolving challenges of RI, emphasizing the need for a combined approach of advanced technologies and human expertise. It highlights how Freyr leverages AI-driven tools, real-time web crawlers, and local Subject Matter Experts (SMEs) to deliver accurate, up-to-date, and actionable regulatory insights. It further outlines the flexible delivery models offered through Freya.Intelligence—including infrastructure-as-a-service, managed services, and custom solutions—to meet the diverse needs of global regulatory teams.

Through practical examples and implementation strategies, the paper underscores the importance of customizable platforms, seamless data integration, and effective dashboarding for enabling strategic foresight and operational efficiency. The ultimate goal: a measurable transformation in RI through reduced workloads, faster decision-making, and simplified compliance—demonstrated by real-world results and significant efficiency gains from Freya.Intelligence deployments.