Eliminate the Risk of Technical Rejection

Synchrogenix's GlobalSubmit VALIDATE is the industry's most robust software platform for assessing the technical validity of an electronic regulatory submission. VALIDATE is a web-based application that checks for over 200 error conditions of varying severity levels. No other program can provide such comprehensive error detection. 

As the validation platform used exclusively by the U.S. Food and Drug Administration (FDA) to assess the validity of thousands of submissions annually passing through its gateway, VALIDATE is designed to successfully integrate with all existing publishing applications. 

VALIDATE supports the most up-to-date criteria for FDA, European Medicines Agency (EMA), Health Canada, NeeS, Swissmedic, and numerous other regions.

Users can initiate the loading and validation process manually (using a browser-based interface) or automatically (by launching a web service). Once a submission has been loaded and analyzed, REPORTS breaks down results across sequences and applications according to preferences by the end user. 

The latest version of VALIDATE supports fully-automated submissions, a recent development at the FDA engineered to speed the drug approval process. Sponsors using an outdated validation platform are now more vulnerable than ever to technical rejection. 

Features

Robust Validation Engine

Supports over 200 error conditions including 40+ PDF checks.

Regional Support

Submissions validate according to applicable regional rules. 

Ready for the Next Generation 

VALIDATE is ready for the next generation – Regulated Product Submissions (RPS). VALIDATE is the only validation solution that can build an RPS backbone. This solution supports medical device 510k's and other submission types as well. 

REPORTS

Once a submission has been loaded and analyzed, REPORTS breaks down results across sequences and applications according to preferences selected by the end user. REPORTS also includes guidance on locating and fixing errors. 

Incremental Loading

The system only reprocesses files that have changed. 

Submit the following form to speak to a representative about GlobalSubmit VALIDATE.