Pharmaceutical regulation is increasingly complex, driving the adoption of technology to streamline compliance and accelerate drug approvals. Since the 1980s, regulatory tech has evolved from paper-based processes to cloud RIM platforms and now to AI-driven augmentation. IQVIA outlines a model for the augmented regulatory worker, where automation, AI, NLP, and LLMs reduce manual workload, enhance intelligence gathering, and enable faster, higher-quality submissions. Key enablers include strong data governance, integrated RIM systems, regulatory intelligence, and advanced automation such as content generation. These solutions free professionals to focus on strategy, improving efficiency and patient access.

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