About EU NeeS Compiler
NeeS Compiler, a part of eCTD Office, is a next generation off-the-shelf Windows application for building
error-free non-eCTD electronic submissions.
Get a personalized free quote on NeeS Compiler: features, license types, services, prices.
NeeS Compiler provides tools for quick and intuitive construction of complex, valid non-eCTD electronic submissions.
NeeS Compiler runs on various Windows based platforms and provides:
- off-the-shelf (no extra server components needed) NeeS construction and validation system,
- integration with SharePont / Documentum (and other DMSs of your choice),
- 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 EU specific regional validation rules,
- customizable validation rules to allow the preparation of NeeS submission specific to your country,
- 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 ...
NeeS - Non-eCTD Electronic Submissions
A non-eCTD electronic submission (NeeS) is any submission of electronic information sent by an
applicant to an agency in support of a marketing authorisation application procedure. This
might be information relating to the initial application or to post-authorisation activity.
A NeeS is formatted as a simple set of electronic files and
folders, usually now broadly organised into module ("M") folders as per the paper CTD
guidance. The files contained are usually PDF or other file formats as appropriate. Each
non-eCTD electronic submission is a standalone submission, a reproduction as far as
possible of the paper dossier.
The eCTD as a specific format is, quite simply, an electronic version of the Common
Technical Document (CTD). The CTD was developed by the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH)
NeeS electronic submissions comply fully with the folder and file organisation as presented in the
ICH eCTD Specification Document. The only difference is that the
two relevant XML files, the index.xml and eu-regional.xml for the backbone of Modules 2 to 5 and
Module 1 for the EU, respectively and the util folder are not present.
Have a few NeeS submissions you need to prepare in the coming week, month?
Get NeeS Compiler FOR RENT!
Here's how it works: instead of purchasing a standard 1-year NeeS Compiler license, you rent NeeS Compiler for a month or even a week - when you actually have submissions you have to publish!
Convert NeeS to eCTD
When NeeS is created, "upgrade" it to an eCTD submission using eCTD Compiler.
If you would like the eCTD Office Suite to be demonstrated at your location please complete the contact form.
FULL Support for GCC (SFDA) eCTD
FREE eCTD Lifecycle Viewer
Full Support for US FDA eCTD
Full Support for TGA (Australia) NeeS
VNeeS Compiler - full support for VNeeS 2.0
New Release February 2011
Announcing Partner Program
Supporting Swissmedic 1.1
NeeS Compiler Facts
Is being used by by more than 100 pharma companies and eCTD consultants all over Europe.
Integrates into your document management system.
Saves time (and money)!
Using NeeS Compiler You Can
Create valid 1.4 EU eSubmissions.
Import / export files from SharePoint / Documentum (and other DMSs of your choice).
Create NeeS templates.
Share / colaborate your NeeS compilations with other NeeS Compiler users in multiuser environments.
Convert MS Word to PDF at export.
Split / merge PDF documents.
Create / auto-correct PDF hyperlinks.
Generate eTOC files.
Construct "working documents" data.
Convert / Merge eCTD to NeeS.
Merge NeeS to NeeS.
Create pCDT for your eCTD.
NeeS Compiler Screenshots
nees compiler validation configuration
nees compiler working area
nees compiler eTOCs
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