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 Sponsors using outdated validation software are now more vulnerable than ever to technical rejection.

Your eCTD submissions validate according to applicable regional rules

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

  • US FDA
  • European Medicines Agency (EMA)
  • Health Canada
  • Swissmedic
  • Australia’s Therapeutic Goods Administration
    (TGA)
  • Japan’s Pharmaceuticals
    and Medical Devices Agency (PMDA)
デモリクエスト
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
お問合せ

トップに戻る
Powered by Translations.com GlobalLink OneLink Software