eCTD Office

About Swiss / CH eCTD Compiler

Swiss / CH 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 Swiss electronic submissions.

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

Swiss / CH eCTD Compiler runs on various Windows based platforms and provides:

• off-the-shelf (no extra server components needed) eCTD 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 CH specific regional validation rules,
• customizable validation rules to allow the preparation of eCTD submission specific to Switzerland / SwissMedic,
• 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 (CH and non-CH) eCTD submissions into a new / renewal submission with leaf operation re-assigning,
• and much more ...

Swiss / CH eCTD Compiler is regularly updated in the light of changes in the SwissMedic / ICH eCTD specification.

SwissMedic eCTD

eCTD is the only valid format for electronic-only submissions to the Swiss Agency for Therapeutic Products (Swissmedic).

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.

eSubmissions as simple as 1-2-3!

Swiss / CH eCTD Compiler was designed to be your choice for eCTD submissions for Swiss Medic.

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If you would like the eCTD Office Suite to be demonstrated at your location please complete the contact form.