Comparison of offers

Premium Enterprise
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Dossier formats

eCTD – electronic Common Technical Document X X
NeeS – Non eCTD electronic submission X X
vNeeS – veterinary Non eCTD electronic submission X X
Paper CTD (PDF) – Common Technical Document X X

Building and publication functions

Dossier storage and archiving X X
Generation of publication X X
Hyperlink & bookmark management X X
Internal validator (before and after publication) X X
Table of content, header, footer and numbering management X X
Publication visualization X X
eCTD sequence management (dossier lifecycle) X X
Collaborative work (check-in / check-out) X X

Specific to paper dossiers

PDF publication (paper publication) X X
Automatic volume creation X X
Creation and printing of margin hyperlinks X X

Other functionalities

21 CFR part 11 traceability X X

Settings and configuration

Document and dossier type configuration X X
Completely configurable system X X
Ennov Doc EDM software – pre-configured X X
Ennov Process option X
eCTD import module Option X X

Support and maintenance

Technical support Included Contract
Minor updates Included Contract
Major updates Included License

Server settings

Secure data center X
Data backups X


Monthly or annual subscription X
Per sequence subscription
Training X X
First publication follow-up offer Option Option
Adaptation of initial configuration X
Complete configuration according to your specific needs X
Perpetual license X
Annual support and maintenance X
Installation X
Database administration X
Server / operating system / database X
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