Offering the richest functionality, powerful tools, and a single, easy-to use interface, Liquent InSight® Publisher enables you to quickly and easily create, review, and amend regulatory dossiers, and submit them for market approval.

Overview

Quickly and easily create, review, amend and submit regulatory dossiers.

WITH LIQUENT INSIGHT PUBLISHER, YOU CAN:

1. Enhance your organization's efficiency, reduce your time to market, and be assured of compliance with the latest regulatory guidelines and specifications.
2. Access eCTD templates for each region in which you are submitting.
3. Drag and drop multiple documents to speed up the submissions process.

WHY CHOOSE LIQUENT INSIGHT PUBLISHER?

1. Submissions wizards: streamline the initiation of submissions that comply with ICH, Japanese, EU, US, STF, and Canadian specifications.
2. Compliant eCTD submission: including the required ICH, STF, and regional XML files, the correctly named leaf files and folder structures, and any requisite navigation aids.
3. Intuitive management: make subsequent amendments, supplements and variations to your submission in the context of the full application.
4. Comprehensive, built-in templates: create multiple submissions in multiple regions.
5. Automatic PDF transform: distill multiple file formats into enhanced PDFs with bookmarks and hyperlinks.
6. Publishing readiness report: lists missing documents, renditions, and eCTD metadata.

Seamless integration: integrates with existing ERDMS systems such as Liquent InSight® Foundation.