How AI Is Revolutionizing Regulatory Compliance in Life Sciences
DOI:
https://doi.org/10.63282/3050-922X.ICRCEDA25-144Keywords:
Artificial Intelligence, Compliance, Life Sciences, Medical Devices, Natural Language Processing, Regulatory Affairs, Submission AutomationAbstract
Regulatory compliance in life sciences remains one of the most time-consuming and high-stakes domains in industry today. As global regulations grow more complex and fragmented, compliance professionals often spend months preparing submissions that are still prone to rejection. Recent advances in artificial intelligence (AI) particularly retrieval-augmented generation, domain-specific language models, and natural language interfaces are beginning to shift this dynamic. This paper explores how AI is transforming compliance workflows, from document retrieval and predicate mapping to automated drafting and predictive analysis. We examine the technical infrastructure enabling these capabilities, including structured data formats, language model maturity, and evolving regulatory acceptance. Key benefits include faster time to market, reduced consultant dependency, and significant operational efficiency gains. Critical risks such as model hallucination, overreliance, and regulatory skepticism are addressed, along with strategies for responsible implementation. We conclude with a forward-looking perspective on predictive compliance and harmonized submissions outlining a future where AI acts not just as a helper, but as a strategic navigator for regulatory affairs teams
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