Use Submissions in Vodori to prepare and track materials submitted to health authorities, including country-specific EMEA submissions and US FDA submissions. Depending on your organization’s configuration, submission workflows guide you through entering required information, tracking waiting periods, recording authority responses, and completing any follow-up document updates or reviews.
Create submission
Create submissions in Vodori to help prepare submissions to health authorities. Submissions can include files from the system, their linked references, uploaded supported materials, and for FDA submissions, an auto-populated 2253 form.
- Click "Submissions" in the navigation.
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Select "Create submission."
- Select the form type.
- Add submission name and complete any other properties on the start screen.
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Select documents to include in the submission package. If applicable, check the options to include references and/or supporting materials that were uploaded in the Viewer.
- Click "Create submission."
From there, the submission in Vodori is used to manage it through its configured tasks, track its workflow state assigned and view its history. The actions available to you depend on the submission’s current state, your organization’s configuration, and your permissions.
Cancel Submission
Based on your permissions, you can stop work on your submission by navigating to the “⋮” icon and select “Cancel submission”.
To retain the submission and resume work later, click “Keep submission”. To confirm cancellation, click “Cancel submission.”
Submission states
| In Submission Prep | Indicates that the submission is being created, or updated prior to formal submission. |
| Submitted to the FDA | Indicates that the submission package has been formally submitted to the FDA for review. |
| Ready for the Dissemination | Indicates that the submission is finalized and approved for promotional or commercial distribution. |
| Cancelled | Indicates that active work on the submission was stopped and canceled. |
Unzip files on Windows 10
The default unzipper on Windows 10 is unable to open documents with file names that contain extended or double-byte characters, like apostrophes. If you have trouble unzipping a submission, try using a different program, such as Winzip, 7-Zip, or ZipGenius, to open the zip file instead of the default unzip tool.
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