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Submission Validation with Lorenz eValidator ONE

The submission validation solution for all regions on your laptop

Basic Validation Profiles for eValidator

eValidator ONE includes all basic profiles addressing the exact requirements as published by the regulatory agencies are available. If you need validation profiles with additional checks or the ability to customize validation profiles, have a look at eValidator FIVE.

Available validation profiles:

  • AU eCTD (TGA)
  • AU NeeS (TGA)
  • BIH NeeS (ALMBIH)
  • CA eCTD (Health Canada)
  • CA Non-eCTD (Health Canada)
  • CA XML PM (Health Canada)
  • CH eCTD (Swissmedic)
  • CH eDok (Swissmedic)
  • CN eCTD (CDE)
  • CN eSubmission (CDE)
  • ECOWAS eCTD (WAHO)
  • ECOWAS eSubmission (WAHO)
  • eCTD MD5/SHA256 Proofreader
  • EU eCTD (EMA)
  • EU NeeS (EMA)
  • EU VNeeS (EMA)
  • GCC eCTD
  • GCC VNeeS
  • KSA NeeS
  • KR eCTD (MFDS)
  • JO eCTD (JFDA)
  • SG eCTD (HSA)
  • TH eCTD (Thai FDA)
  • TW eCTD (TFDA)
  • UA eCTD (SEC)
  • US eCTD 3.2 (US FDA)
  • US eCTD 4.0 (US FDA)
  • US CDRH eCopy (US FDA)
  • WHO PQT eCTD
  • ZA eCTD (SAHPRA)
  • ZA eSubmission (SAHPRA)
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