Regulatory Affairs

Local regulatory support

pharmaceutical research

eCTD / NeeS format preparation solution

Pharmaceutical companies are obliged to submit their dossiers in eCTD or NeeS format (effective from 2019 only eCTD format will be acceptable) to National Regulatory Authorities across the European Union. We can prepare your submissions in ectd / Nees for you.

eCTD or NeeS formats

Acceptance guarantee

Economic solution for the small enterprises

All pharmaceutical companies and their affiliates in the European Economic Area are facing a challenge whether to buy expensive eCTD software solution and to train their regulatory staff to use this. Especially for the small enterprises that need to proceed with only a few regulatory submissions per year (e.g. regulatory variations, new registrations, renewals etc.), this solution is uneconomic.

eCTD or NeeS from paper dossier

With our team of experienced professionals, we are ready to prepare eCTD or NeeS formats of your dossier. We only need your dossier for this submission and we will prepare your ready-to-use eCTD/NeeS format to be submitted to your National Competent Authority. This eCTD / NeeS format will be validated according to the current eCTD / NeeS validation criteria criteria, and will contain no warnings or errors.

You will pay only for the time spent for preparation of your submission. As we want you to feel comfortable, we will send you an estimate of time for the preparation of your submission. in advance, before we start the preparation.

You can try our simple sollution

We guarantee that your eCTD/NeeS format submission will be accepted by your National Competent Authority. We will not change a content of your documents to be submitted - this is your job. Our job is to make only eCTD/NeeS format of the dossier for you.

If you are looking for own software solution, continue to eCTD Submission Software.

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