The Emerging Role of Regulatory Intelligence in Biotechnology: An Integrated Literature Review of Strategic Compliance and Innovation Framework

Abstract

Regulatory intelligence (RI) is an emerging and increasingly fundamental function within regulatory affairs, particularly in the biotechnology sector. Defined by its focus on the systematic collection, analysis, and dissemination of regulatory information, RI supports informed decision-making and strategic planning in a complex and rapidly evolving regulatory landscape. Despite its growing significance, regulatory intelligence remains underrepresented in academic literature. This paper seeks to provide a foundational understanding of the discipline by examining the evolving regulatory landscape, the processes involved in regulatory intelligence, and future considerations for its advancement. Data sources include peer-reviewed publications, regulatory authority documents, web-based articles, and industry blog posts. An integrated literature review identified three core components of regulatory intelligence: (1) information collection, (2) information analysis, and (3) information dissemination. The effectiveness of these components is closely linked to the maturity and integration of systems employed by biotechnology organizations. As regulatory frameworks become more dynamic and digital technologies advance, the role of RI will become increasingly central to proactive compliance, innovation strategy, and global market access.