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

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

In 2019, Prelude Therapeutics, a small cancer drug discovery company, implemented Certara’s GlobalSubmit submissions management software for their electronic common technical document (eCTD) submissions. The regulatory team at Prelude Therapeutics is very lean and responsible for more than 30 submissions annually; therefore, the utmost efficiency in publishing, checking the validation criteria, and reviewing eCTDs is required.

The company found that their eCTD publishing process was not agile enough to meet their needs to implement updates quickly to submissions and provided limited reviewing capabilities through a third party. Without eCTD viewing software, they were unable to review the full scope of their submissions, hindering an effective review process. These challenges resulted in the decision to bring on GlobalSubmit eCTD software to make their regulatory submissions process more efficient.

Following the initial in-depth training provided by Certara, user acceptance testing (UAT) and validation, GlobalSubmit eCTD software was implemented into the regular review process. Hyperlinks and bookmarks are seamlessly created, and quality check (QC) is performed quickly and efficiently using the LINK and CROSSCHECK functionality in GlobalSubmit PUBLISH. With GlobalSubmit VALIDATE, more than 200 error conditions are checked, eliminating the risk of technical rejection. As a result, the QC process for each submission has been reduced from hours to minutes, saving their regulatory team considerable time.

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