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Description: eCTD Editor - registrace léčiv dle formátu eCTD
ema (120) dossier (93) ectd editor (3) sekvence (1) regulační autorita (1)
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.
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 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.
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