eCTD Submission Manager Software

Local regulatory support

CTD Submissin Manager software

eCTD Submission Manager software

Are you looking for own eCTD Submission software solution?

Simple to use

Nees to eCTD on just one click!

Not only NeeS to eCTD convertor

The eCTD Manager works only with your data in NeeS/eCTD folder structure. There is no additional database, extra file repository or any kind of data integration. You just point eCTD Manager to your folder structure, it will validate your submission and create mandatory eCTD files as per the specification. Once you plan switch from NeeS to eCTD, our solution will save a lot of your time. You can create new submission or adjust existing in the eCTD Submission Manager however when preferred you can prepare the eCTD folder structure with your files outside, same as you were doing it for NeeS. You can use eCTD Manager for help like creating empty folder structure, validating, deleting empty folders, etc. At the end eCTD Manager will convert your folder structure into a valid eCTD submission.

Supported standarts

EU: ICH eCTD Specification V 3.2.2, EU M1 v3.0.1 validation criteria 6.1

Do you want to know more about eCTD Submission Manager software?

We would be pleased, when you contact us in case that you are interested in this service.

If you are looking for solution as a service, continue to eCTD / NeeS format preparation solution.