SEI built a generative AI system to draft and check regulatory submission content for a global pharma.

Submissions needed heavy manual coordination between R&D and Commercial teams, and leaders wanted generative AI without compliance risk. SEI structured historical submission data, selected and engineered a custom LLM, ran a proof of concept, and automated content generation with compliance checks. The page reports less manual effort, first-draft recommendations, section validation and flags for missing criteria, with no figures.

SEI is a technology consultancy with a life sciences practice, used by pharma to apply generative AI to regulatory submission content and operations

This sits in the Build stage of the AI use-case lifecycle: Named examples from the foundation-model labs and platforms pharma teams use to actually construct, train and generate the model or application.