EU eCTD Compiler | eCTD Office - Your NeeS / VNeeS / eCTD Publishing Software Solution

About EU eCTD Compiler

EU eCTD Compiler, a part of eCTD Office, is a next generation off-the-shelf eCTD (Electronic Common Technical Document) validation, creation, viewing, manipulation and archiving system for EU electronic submissions.

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The main functionality of the EU eCTD Compiler is the creation of the eCTD XML backbone (electronic dossier submission) along with the lifecycle management. By using the EU eCTD Compiler and its change control process, several topics including lifecycle management and consistency with the eCTD XML DTD are addressed and solved.

eCTD Compiler extends NeeS Compiler by adding eCTD specific features like Envelope creation and lifecycle management.

eCTD Compiler runs on various Windows based platforms and provides:

off-the-shelf (no extra server components needed) eCTD publishing 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,
powerful PDF processing features: conversion to PDF version 1.4, optimization for fast web view, splitting and merging, hyperlinks, ...
easy "Envelope" creation,
auto creation and packaging of eCTD compliant Electronic Submissions for regulatory agencies,
automatic MD5 checksum generation,
Open (applicant's) / Closed (restricted) part export for Active Substance Master Files (ASMF) submissions,
integration with a web browser to enable quick preview of a dossier to be submitted to the authorities,
auto envelope generation from previous sequences,
merging of existing (EU and non-EU) eCTD submissions into a new / renewal submission with leaf operation re-assigning,
and much more ...

MRP/DCP Tracking Table Builder, a part of eCTD Office, is a visual Tracking Table XML builder to be used in the context of Mutual Recognition and Decentralised Procedures, under the Module 1 of the electronic Common Technical Document (eCTD) for the European Union (EU).

EU eCTD Compiler is regularly updated in the light of changes in the EMEA / ICH eCTD specification.

eCTD - Electronic Common Technical Document

The Electronic Common Technical Document allows for the submission of regulatory documentation by pharmaceutical companies to the regulatory authorities. The eCTD specification is an international standard for submitting electronic NDAs (New Drug Applications). The eCTD was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as a standard format for regulatory submissions in the Europe, USA and Japan.

The eCTD is defined as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission.

The eCTD Specification is based on XML technology. An eCTD submission is a collection of data objects that follows the eCTD specification. The main function of the eCTD submission is data exchange. The eCTD submission is composed of the following: folder structure, XML eCTD instance and content files.

The eCTD differs from other electronic submission formats because it is defined by an XML backbone – electronic dossier. While this feature greatly enhances the organization of the submission, it can also be daunting for those involved in its preparation. To generate such a dossier the pharmaceutical industry would need to use special compilation software.