FDA Renews Licenses for Synchrogenix’s GlobalSubmit Software to Review and Validate New Drug and Biologics Applications
Summary
PRINCETON, N.J.--(BUSINESS WIRE)--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 electronic Common Technical Document (eCTD) review software, GlobalSubmit REVIEW™ and GlobalSubmit VALIDATE™ for another year. “We are excited to continue our longstanding partnership with FDA and share news of its legacy license renewal,” said Justin Edge, president of Synchrogenix. “Leading with innovation, we have continued to develop new products that build upon our existing domain expertise to simplify the preparation and review of new drug and biologics applications. Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries.
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