Compiling dossiers for electronic submission

For electronic submissions, we compile dossiers according to the current specifications developed by the ICH, the European Union and Switzerland.
Depending on your requirements, we prepare dossiers as

• eCTD
• NeeS 
• Swiss eDOK

Our services also include converting dossiers from older formats to the current eCTD format in order to prepare baseline submissions.

Save time by combining
dossier writing and eCTD compilation in a single process!

We provide the technical framework and regulatory guidance which enables you to write all sections of the dossier, including Module 3 Quality, in a single streamlined process directly in accordance with the eCTD specification.

Combining dossier writing and eCTD compilation in a single process

• saves time,
• prevents file or email clutter and even
• allows for last minute changes.

Our eCTD project management platform allows multiple people to work on one dossier and integrates document management and version control so that everybody can stay on track.

Since individual sections of the dossier are written in Microsoft Word, the process will be compatible with your office environment.