About AU (TGA) NeeS Compiler

AU NeeS Compiler AU (TGA) NeeS Compiler, part of eCTD Office, ensures the creation of valid Non-eCTD electronic submissions (NeeS) for human medicinal products for Australia's Department of Health and Ageing Therapeutic Goods Administration.

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AU (TGA) NeeS Compiler provides tools for quick and intuitive construction of complex, valid non-eCTD electronic submissions for Australian TGA.

AU NeeS Compiler runs on various Windows based platforms and provides:

  • off-the-shelf (no extra server components needed) NeeS construction and validation system,
  • an easy-to-use intuitive user interface,
  • quick access buttons for commonly used tasks such as submission validation, document merging, adding PDF cross-references, and more.,
  • more than 150 ICH and AU specific regional validation rules,
  • an in-place validation system that helps you resolve naming and other errors during the compilation time,
  • automatic optimization: removal of orphaned files and empty sections,
  • auto generation of the eTOCs (Electronic Table Of Content): CTD-TOC (ctd-toc.pdf) and module TOC files (m1-toc.pdf, m2-toc.pdf, m3-toc.pdf, m4-toc.pdf, m5-toc.pdf),
  • powerful PDF processing features: conversion to PDF version 1.4, optimization for fast web view, splitting and merging, hyperlinks, ...
  • convert non PDF documents to PDF at export,
  • and much more ...
AU NeeS Compiler in action ...

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Latest News:

Full Support for US FDA eCTD
FREE eCTD Lifecycle Viewer
eCTD Office September 2011 - New eCTD / NeeS Validation Fully Supported
VNeeS Compiler - full support for VNeeS 2.0
TIGes released (February 2011) new validation criteria for eCTD (3.0) and NeeS (2.0)
New Release February 2011
Announcing Partner Program
New Release November 2010
Supporting Swissmedic 1.1

eCTD Office Partner Program

We are seeking individuals and companies like yours to expand eCTD Office's presence around the world, grow the satisfied user base, and make our products more accessible to those customers who want the best possible solutions for their e-submission needs.
eCTD Office Partner Program

Using AU NeeS Compiler You Can

eCTD Office Fact!Create valid AU NeeS eSubmissions.

eCTD Office Fact!Import / export files from SharePoint (and other DMSs of your choice).

eCTD Office Fact!Create NeeS templates.

eCTD Office Fact!Share / colaborate your NeeS compilations with other NeeS Compiler users in multiuser environments.

eCTD Office Fact!Convert MS Word to PDF at export.

eCTD Office Fact!Split / merge PDF documents.

eCTD Office Fact!Create / auto-correct PDF hyperlinks.

eCTD Office Fact!Generate TOC files.

eCTD Office Fact!Construct "working documents" data.

eCTD Office Fact!Convert / Merge eCTD to NeeS.

eCTD Office Fact!Merge NeeS to NeeS.

eCTD Office Fact!Create pCDT for your eCTD.