Publishing the Submission Dossier

When the Submission Dossier folder contains all of the necessary files, in the required structure, you can publish it as an eCopy of the submission.

Required access roles: Regulatory Lead of submission project owner

Note: The eCopy publishing options are available only when the submission's publishing file format is set to "eCopy" on the Regulatory Information tab. See Editing Properties for Submission Master Records.
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 publish in the eCopy format. See Opening a Submission. Organize the files and folders in the Submission Dossier in the order that you want them to appear in the published eCopy of the submission. See Organizing the Submission Dossier Structure.
See Also
About eCopy Submissions
eCopy Page
  1. In the navigation pane, click Publishing.
  2. In the eCopy tab, click Publish .
  3. Click OK to clear the informational message.

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

    The Publish 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.
    Single PDF

    Only shows if the submission does not use volumes.

    		Select Yes to publish all of the document files in the submission as a single PDF file. Select No to publish each of the document files in the submission as a separate PDF file.
  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 eCopy submission is published:
    Field NameDescription
    Send Published Notifications To:
    Standard UsersSelect the role whose assigned users should receive notification when the eCopy submission is published:
    • 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 eCopy submission is published.
  7. Click Done.
    The eCopy publishing job has been submitted. Publication notifications will be sent when publication is complete.
  8. Click OK.

All files in the Submission Dossier are converted to PDF using the selected PDF conversion and page layout options. The volumes, published PDF files, and other electronic files in the STATISTICAL DATA and MISC FILES virtual folders are compressed into a zipped eCopy submission file. The zipped file is checked in to the Published Dossier folder on the Local Folder tab. Publication notifications are sent to all selected users.