Browser-based Publish is a cloud-based eCTD application for the assembly and publishing of electronic Common Technical Document (eCTD v3.3 and 4.0) applications in Australia, Brazil, Canada, China, the European Union, Gulf Cooperation Council, Japan, Switzerland, and the US. 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 submission unit 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 submission units, 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 submission unit for a new or existing application
Setting up the submission unit 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 submission unit Table of Contents (TOC)
Providing the submission unit to the designated reviewers to ensure that the content is complete, correct and properly organized
Publishing the submission unit to the file system
Validating the submission unit and correcting any remaining technical errors
Packaging and releasing the submission unit to a regulatory authority
This documentation provides information to aid in completing the submission unit assembly and publishing process.
Background
Access Publish
Basic Features of Publish
Manage Applications
Manage a Submission Unit
Manage Context Groups
Manage Folders and Labels
Manage Files
Manage Links in a PDF File
Manage Contacts