Case Study: Prelude Therapeutics reduces QC submission review from hours to minutes with Certara GlobalSubmit eCTD Software

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, faced inefficiencies in its regulatory submissions process. Their lean team was responsible for over 30 annual submissions, but their previous eCTD publishing process was not agile, provided limited review capabilities, and hindered their ability to perform an effective quality control review. To address this, they implemented Certara’s GlobalSubmit eCTD software.

Following training and validation, Certara’s solution transformed Prelude's process. The software's integrated LINK and CROSSCHECK functionalities in its PUBLISH and VALIDATE modules enabled seamless hyperlink creation and automatic checks for over 200 error conditions. This reduced their quality control process for each submission from hours to minutes, saving the regulatory team considerable time and eliminating the risk of technical rejection.

Prelude Therapeutics

Jessica Pung

Associate Director of Regulatory Operations