PUBLISH

GlobalSubmit PUBLISH is a state-of-the-art application for the assembly and publishing of electronic Common Technical Document (eCTD) applications in the US, EU, Switzerland, Australia, Japan and Canada. PUBLISH allows the documentation created by your authors to be placed in an eCTD table of contents, reviewed and approved and published into a compliant eCTD sequence ready to be delivered to a regulatory authority by an electronic gateway or other approved means.

PUBLISH guides you through the process of creating and structuring eCTD sequences, populating them with documents and data files, reviewing them for errors and finalizing them to submit to a regulatory agency. The major steps in the process are:

•    Creating a sequence for a new or existing application

•    Setting up the sequence structure to include your product’s specific details such as drug substance, manufacturers, dosage forms, studies, etc.

•    Adding the necessary documents (forms, correspondence, reports, data files, etc.) to the sequence Table of Contents (TOC)

•    Providing the sequence to the designated reviewers to ensure that the content is complete, correct and properly organized

•    Publishing the sequence to the file system

•    Validating the sequence and correcting any remaining technical errors

•    Packaging and releasing the sequence to a regulatory authority

This documentation will provide you with the background to complete the sequence assembly and publishing process.

Getting Started
Security
Background
Customizing PUBLISH
Managing Applications
Managing a Sequence
Structuring a Sequence
Saving Changes
Link and Bookmark Management
LINK in PUBLISH
Publishing and Validating a Sequence
Managing States
Managing Standard File Reference Titles
Cloning a Sequence

Note:    This documentation does not cover the eCTD review process. While the reviewing process can be performed in PUBLISH, the reviewing tools provided by GlobalSubmit are covered in the REVIEW documentation.