Glossary
Submission Tracking
What is Submission Tracking?
Submission Tracking is the process of monitoring and managing the progress of regulatory submissions, such as New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), or supplements, throughout the approval process.
What are the key components of submission tracking?
- Detailed submission timeline and milestones
- Regular status updates from regulatory agencies
- Tracking of information requests, deficiencies, and responses
- Coordination with internal teams (e.g., regulatory, clinical, manufacturing)
- Maintenance of submission-related documentation
How does submission tracking ensure regulatory compliance?
Submission tracking ensures regulatory compliance by systematically monitoring and managing the submission of documents to regulatory authorities. It provides real-time updates on the status of submissions, ensuring that deadlines are met, and requirements are fulfilled. This process helps identify and address any deficiencies or missing information promptly. By maintaining organized records of all interactions and submissions, it ensures transparency and traceability. Automated alerts and reminders help keep the process on track, reducing the risk of non-compliance. Overall, it ensures that all regulatory obligations are met efficiently and accurately.
