VALIDATE

Eliminate the Risk of Technical Rejection

GlobalSubmit VALIDATE™ is the industry’s most robust software platform for assessing the technical validity of an electronic regulatory submission. Used exclusively by the U.S. Food & Drug Administration, 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.

eCTD validator Electronic Submissions

As the validation platform used exclusively by the FDA to assess the validity of thousands of submissions passing through its gateway weekly, VALIDATE is designed to successfully integrate with all existing publishing applications.

VALIDATE supports the most up-to-date criteria for US FDA, EMA, Health Canada, NeeS, Swissmedic and numerous other regions. Users can initiate the loading and validation process manually or automatically. Once a submission has been loaded and analyzed, REPORTS™ breaks down results across sequences and applications according to preferences selected 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 Sponsors using an outdated validation platform are now more vulnerable than ever to technical rejection.

VALIDATE not only supports submission across multiple regions, it’s ready for the next generation – Regulated Product Submissions (RPS).

Supported Regions

  • U.S. FDA – 2.01, 3.3
  • EU – 3.01 and NeeS
  • Health Canada – 2.2
  • Australia (TGA) – 3.0
  • Swissmedic – 1.3