Certara, the global model-informed drug development and decision support leader, today announced that the US Food and Drug Administration (FDA) has renewed its legacy licenses for Synchrogenix’s eCTD review and validation software, GlobalSubmit REVIEW and GlobalSubmit VALIDATE for another year. Click here to read the full press release.
These licenses provide enterprise-wide use of the GlobalSubmit software for more than 6,000 users at FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) divisions for reviewing new drug and biologics applications. Synchrogenix is Certara’s regulatory science division.
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.