Validation Profiles for eValidator FIVE
eValidator FIVE 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.
Available validation profiles:
- AU eCTD (TGA)
- AU NeeS (TGA)
- BA eCTD (ALMBIH)
- BA NeeS (ALMBIH)
- CA eCTD (Health Canada)
- CA Non-eCTD (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 3.2 (EMA)
- EU eCTD 4.0 (EMA)
- EU NeeS (EMA)
- EU VNeeS (EMA)
- GCC eCTD
- GCC VNeeS
- KSA NeeS
- KR eCTD (MFDS)
- JO eCTD (JFDA)
- RS Nees (ALIMS)
- SG eCTD (HSA)
- TH eCTD (Thai FDA)
- TN eCTD (ANMPS)
- TN eSubmission (ANMPS)
- 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)
* There is an extended version for the marked profiles.