About US (FDA) eCTD Compiler
US (FDA) eCTD Compiler, a part of eCTD Office, is a next generation off-the-shelf eCTD creation, validation, viewing, manipulation and publishing system for FDA electronic submissions.
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The main functionality of the US (FDA) eCTD Compiler is the creation of the eCTD submission (electronic dossier submission) along with the lifecycle management.
By using the US (FDA) eCTD Compiler and its change control process, several topics including easy STF (study tagging files) generation, lifecycle management and consistency with the eCTD XML DTD and regional validation rules are addressed and solved.
US (FDA) eCTD Compiler runs on various Windows based platforms and provides:
- off-the-shelf (no extra server components needed) eCTD publishing and validation system,
- "STF Builder" - to visually create study tagging files,
- 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 FDA 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,
- powerful PDF processing features: conversion to PDF version 1.4, optimization for fast web view, splitting and merging, hyperlinks, ...
- easy "Admin elements" creation,
- auto creation and packaging of eCTD compliant Electronic Submissions,
- Open (applicant's) / Closed (restricted) part export for Active Substance Master Files (ASMF) submissions,
- auto admin elements generation from previous sequences,
- merging of existing (FDA and non-FDA) eCTD submissions into a new / renewal submission with leaf operation re-assigning,
- and much more ...
US (FDA) eCTD Compiler is regularly updated in the light of changes in the FDA / ICH eCTD specification.
eSubmissions as simple as 1-2-3!
US (FDA) eCTD Compiler was designed to be your choice for eCTD submissions for FDA.
If you would like the eCTD Office Suite to be demonstrated at your location please complete the contact form.