eCTD Editor®

The eCTD Editor®allows you to submit documents to the regulatory authority in the EU (EMA or national authorities), USA (FDA), Canada (Canada Health), Switzerland(Swissmedic) and Australia (TGA) in eCTD format. The submissions meet ICH specifications ICH (M2 - M5 modules). The eCTD Editor® allows you to generate also submissions in the NeeS format.


Increase Your Productivity

The editor is so easy that we will be happy to offer you an unlimited support for the first month of use. See the features and manual.


Choose your Edition Starter, Single MAH, Registrator

Choose the edition of the eCTD Editor that suits you best. Starter – accessible only through the Internet, you pay only when you use it. Single MAH or Registrator are permanent licenses. Is it not enough for you the eCTD Editor for Europe, the USA or Canada? Do you need an eCTD Editor e.g. for South Africa or Thailand? The solution is coming soon - we are working on it.


Buy support

Get the warranty of support and updates on the latest validation criteria. New versions according to new specification updates are free (included in the support costs).


Get started

Start working, run the eCTD Editor online.
If you already have a Starter Edition access or are running your solution in our cloud, log in to the eCTD Editor.


Autorem webu je společnost Human Ways. Tato společnost se zabývá vývojem software eCTD Editor, software na výrobu léčiv Orgnes a software na formalizaci řízení dle GAMP - Síť vztahů.


Ochranná známka

eCTD Editor® je kombinovaná ochranná známka vlastněná společností Human Ways, s.r.o. evidovaná Úřadem průmyslového vlastnictví České republiky pod číslem registrace 324409.