Posts by fnanovic

FDA awards Synchrogenix contract extension for eCTD Management Software

By on Wednesday, July 19, 2017 in Industry Updates

On June 15th, the United States Food and Drug Administration (US FDA) awarded Synchrogenix a contract extension for the electronic common technical document (eCTD) submission management software: GlobalSubmit REVIEW™ & GlobalSubmit VALIDATE™ This contract extension provides a continuity in the drug review process and marks the 12th anniversary of the exclusive...

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FDA upgrades eCTD environment

By on Wednesday, July 19, 2017 in Industry Updates

FDA upgrades eCTD environment to newest version of GlobalSubmit VALIDATE The US Food and Drug Administration (US FDA) has upgraded their GlobalSubmit VALIDATE™ suite as of July 10th, 2017 implementing the new eCTD validation criteria for Study Data Technical Conformance. This upgrade focuses on new eCTD validation changes, including new High Level validation errors...

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