Regulatory Affairs Submission and Tracking Process

Start of the Workflow/Process.

Retrieve all active regulatory submission entries that are currently in the 'Draft' or 'Review' stage.

Create a new entry in the Submission Data Model to start the tracking process for a new product/molecule.

Create a task for the assigned Regulatory Affairs Specialist to begin document compilation.

Update the status of the submission entry to 'In Review' once the dossier is compiled.

Create a task for the QA team to verify the accuracy and completeness of the dossier against the checklist.

Calculate the target submission date by adding the required regulatory lead time to the current date.

Fetch specific country-level regulatory requirements from the Requirements Data Model based on the target market.

Update the Submission entry with the specific requirements retrieved from the requirements model.

Create a task to assemble all technical documents, certificates, and labels into the final submission package.

Send an automated email to the relevant Health Authority contact upon successful submission.

Update the Submission entry status to 'Submitted' and record the submission timestamp.

Get all 'Request for Information' (RFI) entries related to the current submission.

Create an urgent task for the specialist to address and upload responses to authority queries.

Aggregate all completed submissions in the current year to calculate the percentage of approved vs. rejected submissions.

Create a comprehensive report summarizing all active, submitted, and approved regulatory submissions for the month.

Send an email to the Product Management and Manufacturing teams regarding the submission status change.

Delete or archive redundant draft versions of the dossier from the data model to maintain cleanliness.

End of the Workflow/Process.