FDA Renews Certara eCTD Legacy Licenses

FDA has renewed the legacy licenses for Certara’s Synchrogenix division’s electronic common technical document (eCTD) review software, GlobalSubmit Review and GlobalSubmit Validate, for another year. The agency has been using the software since 2005.

Certara says the licenses provide enterprise-wide use of the GlobalSubmit software for more than 6,000 users at CDER and CBER for reviewing new drug and biologics applications. Synchrogenix is Certara’s regulatory science division.

Certara says GlobalSubmit Review facilitates the regulatory review process by providing both the sponsor and FDA with an identical vantage point, ensuring that each regulatory activity can be filed and viewed according to regulations. GlobalSubmit Validate is used exclusively by FDA to assess the technical validation criteria of all eCTD submissions passing through its electronic submissions gateway, confirming compliance standards are met, the company says.