Eliminate your risk of technical rejection with eCTD validation software

Certara’s GlobalSubmit VALIDATE assesses the technical validity of your regulatory submissions and eliminates the risk of technical rejection. GlobalSubmit VALIDATE is a web-based application that checks for over 200 error conditions of varying severity levels, including 40+ PDF checks. In fact, VALIDATE has processed over 1.5 million regulatory submissions.

Our validation software supports fully automated eCTD submissions and is designed to successfully integrate with all existing eCTD publishing applications. Sponsors using outdated validation software are now more vulnerable than ever to technical rejection.

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Your eCTD submissions validate according to applicable regional rules

GlobalSubmit VALIDATE supports the most up-to-date criteria for:

  • US FDA
  • 欧洲药品管理局 (EMA)
  • 加拿大卫生部
  • Swissmedic
  • 澳大利亚医疗用品管理局 (TGA)
  • Japan’s Pharmaceuticals
    and Medical Devices Agency (PMDA)
Why GlobalSubmit VALIDATE?
  • Ready for Regulated Product Submissions (RPS) – VALIDATE can build an RPS backbone and supports other submission types as well
  • REPORTS – Breaks down results across sequences and applications according to preferences selected by the end user and provides guidance on locating and fixing errors
  • Incremental loading – VALIDATE only reprocesses files that have changed

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