Packaging the Submission Dossier

When the Submission Dossier folder contains all of the necessary files, in the required structure, you can package it as a ZIP file for further distribution to third party vendors for eCOPY, eCTD, and Summary Technical Document manual submission. The packaging process produces a ZIP file and a log file that lists all files processed, which are then checked into the submission's Published Dossier folder. The ZIP file contains all documents that could be converted to PDF and a TOC file listing the dossier's folder structure and documents.

Required access role: Regulatory Lead

Important: This app stores personal data in some settings. To follow good personal data management practices, Business Administrators might need to edit these settings to remove personal data, such as names, email addresses, and phone numbers.

Before you begin: Open the submission project that you want to package. See Opening a Submission.
  1. In the navigation pane, click Package.
  2. In the Package tab, click Package .
  3. Click OK to clear the informational message.

    Note: You cannot include files with embedded attachments or password-protected files in the submission dossier.

    The Package Submission Dossier pane opens.
  4. Select the settings to be used during the PDF conversion process:
    Field NameDescription
    PDF Options:
    PDF VersionSelect the Adobe Acrobat version to be used when converting the documents to PDF.
  5. Select the page layout settings to be used in each PDF file created:
    Field NameDescriptionOptions
    Header:
    LeftSelect the submission attribute that you want to appear in the left side of the header on each page.
    • None
    • License Number
    • Region
    • Country
    • State
    • Title
    • Owner
    • Company Name
    • Submission Type
    • Current Date
    • Page Number
    CenterSelect the submission attribute that you want to appear in the center of the header on each page.
    RightSelect the submission attribute that you want to appear in the right side of the header on each page.
    Footer:
    LeftSelect the submission attribute that you want to appear in the left side of the footer on each page.
    • None
    • License Number
    • Region
    • Country
    • State
    • Title
    • Owner
    • Company Name
    • Submission Type
    • Current Date
    • Page Number
    CenterSelect the submission attribute that you want to appear in the center of the footer on each page.
    RightSelect the submission attribute that you want to appear in the right side of the footer on each page.
    Watermark:
    OrientationSelect the orientation of the watermark on each page.
    • Cross
    • Horizontal
    • Vertical
    ValueSelect the submission attribute that you want to be used as the watermark on each page.
    • None
    • License Number
    • Region
    • Country
    • State
    • Title
    • Owner
    • Company Name
    • Submission Type
    • Current Date
    • Page Number
  6. Select the users who should be notified when the submission is packaged:
    Field NameDescription
    Send Published Notifications To:
    Standard UsersSelect the role whose assigned users should receive notification when the submission is packaged:
    • Submission Leads
    • Submission Owners
    • Submission Members
    • Regulatory Administrators
    Other UsersClick to search for and select users not assigned to one of the selected roles who should receive notification when the submission is packaged.
  7. Click Done.
    The packaging job is submitted.
  8. Click OK.

All files in the submission dossier that can be are converted to PDF using the selected PDF conversion and page layout options. Any files that cannot be converted to PDF are listed in the log file that is included in the final package. The zipped file is checked in to the Published Dossier folder in the Local Folder tab. Notifications are sent to all selected users when packaging is complete.