Configuring eCopy Submissions

You can control how eCopy submissions are structured. The default values conform to the FDA format.

  1. Create or open the text file for customized properties. For more information, see Editing Properties Using MQL.
  2. To define the name of the submission dossier that contains the organized volumes and files that will be published as an eCopy submission, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object: 

      Regulatory.eCopy.Configuration.FolderName.SubmissionDossier=Submission Dossier

    2. Set the name of the folder depending on your business requirements.
  3. To define the name of the controlled folder that contains the submission dossier files, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object: 

      Regulatory.Submission.SubmissionDossierFolderName=Submission Dossier

    2. Set the name of the folder depending on your business requirements.
  4. To define the name of the controlled folder that contains a zipped copy of the published submission dossier files, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object: 

      Regulatory.Submission.PublishedDossierFolderName=Published Dossier

    2. Set the name of the folder depending on your business requirements.
  5. To define the maximum size for an individual PDF in an eCopy submission, follow these steps:
    1. Add or edit this line in the file used to import properties into a page object: 

      Regulatory.eCopy.PDF.FileSizeMBLimit=50

    2. Set the maximum size of the PDF file depending on your business requirements.
  6. When finished updating the text file with all properties you want to modify, including the ones shown here, use the text file to modify the Regulatory.properties page object. For more information, see Editing Properties Using MQL.