AU/NZ NeeS Compiler

AU/NZ NeeS Compiler - TGA/Medsafe Non-eCTD

AU/NZ NeeS Compiler, a part of eCTD Office, is an authenticated NeeS preparation, creation, manipulation, validation and publishing system for TGA/Medsafe electronic submissions for human medicinal products.

eCTD Office produces valid TGA/Medsafe NeeS electronic submissions .

Provides tools for quick and intuitive construction of complex, valid non-eCTD electronic submissions.

AU / NZ NeeS Compiler in Action!

The main functionality of the AU/NZ NeeS Compiler is the creation of valid TGA/Medsafe 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 TGA's Guidance for Non-eCTD electronic Submissions (NeeS) for human medicinal products in Australia and New Zealand.

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