EU NeeS Compiler

EU NeeS Compiler - European Non-eCTD

EU NeeS Compiler, a part of eCTD Office, is a NeeS creation, manipulation, validation and publishing system for EU electronic submissions for human medicinal products.

eCTD Office produces valid European NeeS electronic submissions: national, centralised, MRP (mutual-recognition) or DCP (decentralised).

Fully compliant with EU Module 1 Specification, version 2.0 and EU NeeS Validation Criteria, version 4.0.

EU NeeS Compiler in Action!

The main functionality of the EU NeeS Compiler is the creation of valid European electronic Non-eCTD dossier submissions along with hyperlinked CTD-TOC and Module TOC generation.

Built in validation supporting regional rules ensures no invalid submissions can be generated.

Conforms to TIGes Harmonised Guidance for Non-eCTD electronic Submissions (NeeS) for human medicinal products in the EU.

Regularly updated following the changes in the EMEA / ICH eCTD specification.