Begin with Phase 1 - Preliminary evaluation of submission.Go to Phase 2 - Risking assessment and approval.Go to either Phase 3A - Medium and low risk submissions development or Phase 3B - High risk submissions development.If medium or low risk submission, go to Phase 5 - Implement compliance strategy, risk mitigations, and exit strategy. This is the end of the process.If high risk submission, go to Phase 4 - Compliance strategy recommendation and approval, then go to Phase 5 - Implement compliance strategy, risk mitigations, and exit strategy. This is the end of the process.