REGULATORY AFFAIRS SUBMISSION AND TRACKING PROCESS

Created by ChecklistGuro (https://checklistguro.com)

[ ] Fetch Pending Submissions: Retrieve all active regulatory submission entries that are currently in the 'Draft' or 'Review' stage.
[ ] Initialize Submission Record: Create a new entry in the Submission Data Model to start the tracking process for a new product/molecule.
[ ] Assign Regulatory Specialist: Create a task for the assigned Regulatory Affairs Specialist to begin document compilation.
[ ] Update Submission Status: Update the status of the submission entry to 'In Review' once the dossier is compiled.
[ ] Quality Assurance Review: Create a task for the QA team to verify the accuracy and completeness of the dossier against the checklist.
[ ] Calculate Submission Deadline: Calculate the target submission date by adding the required regulatory lead time to the current date.
[ ] Check Regulatory Requirements: Fetch specific country-level regulatory requirements from the Requirements Data Model based on the target market.
[ ] Append Requirements to Dossier: Update the Submission entry with the specific requirements retrieved from the requirements model.
[ ] Final Dossier Compilation: Create a task to assemble all technical documents, certificates, and labels into the final submission package.
[ ] Notify Regulatory Authority: Send an automated email to the relevant Health Authority contact upon successful submission.
[ ] Mark as Submitted: Update the Submission entry status to 'Submitted' and record the submission timestamp.
[ ] Retrieve Pending Queries: Get all 'Request for Information' (RFI) entries related to the current submission.
[ ] Respond to Health Authority Queries: Create an urgent task for the specialist to address and upload responses to authority queries.
[ ] Calculate Submission Success Rate: Aggregate all completed submissions in the current year to calculate the percentage of approved vs. rejected submissions.
[ ] Generate Monthly Compliance Report: Create a comprehensive report summarizing all active, submitted, and approved regulatory submissions for the month.
[ ] Internal Stakeholder Update: Send an email to the Product Management and Manufacturing teams regarding the submission status change.
[ ] Archive Obsolete Drafts: Delete or archive redundant draft versions of the dossier from the data model to maintain cleanliness.

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