Regulatory Submission Dossier Management

Start of the Workflow/Process.

Create a new entry in the Dossier Data Model to start the submission lifecycle.

Update the status field of the Dossier entry (e.g., from 'Draft' to 'Review').

Assign a task to the Regulatory Specialist to review the completeness of the dossier.

Fetch all associated document entries (CMC, Clinical, Non-clinical) linked to the Dossier.

Calculate the submission deadline based on the Dossier creation date plus a fixed regulatory lead time.

Count the number of entries in the Document Model where the 'Status' field is not 'Finalized'.

Create a task for the QA team to verify the dossier against the checklist requirements.

Update the Dossier entry to set a 'Flagged' boolean to true if errors are found during review.

Send an automated email to the Regulatory Lead when the QA Audit task is marked as complete.

Retrieve specific regulatory requirements from the Global Requirements Data Model based on the target region.

Create a task to compile all approved document entries into the final submission format.

Create a new entry in the Submission History model to record the final submission event.

Create a summary report showing the progress of all modules within the current dossier.

Send an email to the distribution list notifying them that the dossier has been officially submitted.

Delete temporary or superseded document entries from the data model after final assembly.

End of the Workflow/Process.