REGULATORY SUBMISSION DOSSIER MANAGEMENT

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[ ] Initialize Submission Dossier: Create a new entry in the Dossier Data Model to start the submission lifecycle.
[ ] Update Dossier Status: Update the status field of the Dossier entry (e.g., from 'Draft' to 'Review').
[ ] Regulatory Affairs Review: Assign a task to the Regulatory Specialist to review the completeness of the dossier.
[ ] Retrieve Document Metadata: Fetch all associated document entries (CMC, Clinical, Non-clinical) linked to the Dossier.
[ ] Calculate Submission Deadline: Calculate the submission deadline based on the Dossier creation date plus a fixed regulatory lead time.
[ ] Aggregate Missing Document Count: Count the number of entries in the Document Model where the 'Status' field is not 'Finalized'.
[ ] Quality Assurance Audit: Create a task for the QA team to verify the dossier against the checklist requirements.
[ ] Flag Dossier Inconsistency: Update the Dossier entry to set a 'Flagged' boolean to true if errors are found during review.
[ ] Notify Regulatory Lead of Completion: Send an automated email to the Regulatory Lead when the QA Audit task is marked as complete.
[ ] Fetch Submission Requirements: Retrieve specific regulatory requirements from the Global Requirements Data Model based on the target region.
[ ] Final Dossier Assembly: Create a task to compile all approved document entries into the final submission format.
[ ] Generate Submission Log: Create a new entry in the Submission History model to record the final submission event.
[ ] Generate Submission Readiness Report: Create a summary report showing the progress of all modules within the current dossier.
[ ] Alert Stakeholders of Submission: Send an email to the distribution list notifying them that the dossier has been officially submitted.
[ ] Remove Obsolete Drafts: Delete temporary or superseded document entries from the data model after final assembly.

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