AI, ML, NLP, and RPA are transforming regulatory processes by automating routine tasks, enabling real-time compliance monitoring, and improving decision-making. IQVIA’s ecosystem includes the Regulatory Intelligence Assistant, orchestrated workflows, AI-driven RIMS, and automated content generation. These tools reduce errors, enhance efficiency, and institutionalize knowledge across regulatory teams. Benefits include faster submissions, dynamic reporting, improved resource utilization, and evidence-based strategies. As eCTD 4.0 shifts toward data-driven submissions, AI ensures accuracy and proactive compliance. This transformation positions regulatory operations as agile, efficient, and future-ready in a complex global landscape.

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