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Submission Validation with Lorenz eValidator Enterprise

The submission validation solution for mid- to large-sized enterprises

Validation Profiles for eValidator Enterprise

eValidator Enterprise includes current and previous validation criteria addressing the exact requirements as published by the regulatory agencies. In addition, it offers extended profiles with additional checks. With eValidator Enterprise you also have the ability to customize profiles.

Available validation profiles:

  • AU eCTD (TGA)
  • AU NeeS (TGA)
  • CA eCTD (Health Canada)
  • CA Non-eCTD (Health Canada)
  • CH eCTD (Swissmedic)
  • CN eCTD (CDE)
  • eCTD MD5 Proofreader
  • EU eCTD | NeeS (EMA)
  • EU VNeeS (EMA)
  • GCC eCTD and KSA NeeS
  • JO eCTD (JFDA)
  • PDF QC (US FDA Requirements)
  • TH eCTD (Thai FDA)
  • US eCTD (US FDA)
  • US CDRH eCopy (US FDA)
  • ZA eCTD (MCC)

Extended validation profiles:

  • AU NeeS extended
  • CH eCTD extended
  • EU eCTD extended
  • GCC eCTD extended
  • JO eCTD extended
  • JP eCTD extended
  • KSA NeeS extended
  • TH eCTD extended
  • US eCTD extended
  • ZA eCTD extended
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