eCTD Office

About 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.

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, ...
• 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.

Convert NeeS to eCTD

When NeeS is created, "convert" it to an eCTD submission using eCTD Compiler.

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