Mentioned in 2 AI use cases across 1 industries
Certara worked with Brazil’s regulator so drug companies can send newer eCTD 4.0 application packages through GlobalSubmit instead of older, more manual methods.
FDA used the safety-review workflow to decide whether Entresto's pediatric warning label needed changes, and the reviewed data did not show a new problem.
AI helps check whether drug safety cases are complete and consistent, keeps a record of why decisions were made, and prepares reports in the right format for different regulators.