Submissions from the U.S. FDA Point of View
Synchrogenix is the exclusive provider of electronic common technical document (eCTD) viewing and validation software to the U.S. Food and Drug Administration (FDA). When sponsors use the FDA's decision support system prior to submitting, they eliminate the risk of technical rejection.
Synchrogenix’s GlobalSubmit REVIEW facilitates the regulatory review of the electronic submission process by providing sponsors and reviewers with an identical vantage point. With this shared perspective, sponsors can have confidence that their submission is properly formatted and that no technical errors remain in the submission, thus eliminating the risk of technical rejection.
Transparency Translates to Confidence
Miscommunication ranks as the number one reason for delay in the review process of electronic submissions according to the FDA. Fortunately, these costly interruptions are preventable.
Competitors' products can take up to thirty minutes to open a 100,000 page application, compared to REVIEW, which takes less than five seconds.
Share screens with reviewers via hyperlinks.
View your application's cumulative, sequence, current, and regulatory activities.
An identical vantage point with the FDA improves sponsor-agency communication.
Complies with eCTD, NeeS, and RPS formats when implemented.