About US (FDA) eCTD Compiler

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.

Get a personalized free quote on US (FDA) eCTD Compiler: features, services, prices.

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 in action ...

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.

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

Latest News:

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

US (FDA) eCTD Compiler Facts

eCTD Office Fact!Ensures NO "Refuse To File".

eCTD Office Fact!Includes a visual STF Builder.

eCTD Office Fact!Saves time (and money)!

Using US (FDA) eCTD Compiler You Can

eCTD Office Fact!Understand FDA Module 1 Regional eCTD.

eCTD Office Fact!Create valid FDA eSubmissions.

eCTD Office Fact!Visually create STFs.

eCTD Office Fact!Create eCTD templates.

eCTD Office Fact!Share / colaborate your eCTD compilations with other eCTD Compiler users in multiuser environments.

eCTD Office Fact!Convert MS Word to PDF at export.

eCTD Office Fact!Split / merge PDF documents.

eCTD Office Fact!Create / auto-correct PDF hyperlinks.

eCTD Office Fact!Merge NeeS to eCTD.

eCTD Office Fact!Merge eCTD to eCTD.

eCTD Office Fact!Import non-FDA eCTDs.

eCTD Office Fact!Import / export files from SharePoint / Documentum (and other DMSs of your choice).

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