Prelude Therapeutics reduces their quality control (QC) process for regulatory submissions from hours to minutes with Certara's GlobalSubmit eCTD Software

Prelude Therapeutics, a small cancer drug discovery company handling more than 30 electronic submissions (eCTD) annually with a lean regulatory team, found its prior third-party solution couldn't display full submission scope, hindering effective quality review. In 2019 Prelude deployed Certara's GlobalSubmit software, using its PUBLISH, VALIDATE, CROSSCHECK, and WebReview functionality, which automatically creates hyperlinks and bookmarks while checking more than 200 error conditions for compliance. As a result, the QC process for each submission was reduced from hours to minutes, real-time validation eliminated technical rejection risk, and eCTD requirement updates are applied automatically. Jessica Pung, Associate Director of Regulatory Operations, said: "GlobalSubmit is a really good platform because it is all integrated...you know when you generate the submission that it is compliant."

Certara is a biosimulation software company (Simcyp, Phoenix) whose PK/PD and QSP models predict drug behavior in the body; the FDA itself licenses Certara's software to review sponsor submissions.

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.