PREPARE, REVIEW AND SUBMIT
Format: CTD Guideline (ICH/RoW)
Module 1 – Administrative Information and Prescribing Information
Module 2 – CTD Summaries (Quality Overall Summary, Nonclinical & Clinical Overview)
Module 3 – Quality (S part – DMF & P Part – Finished Product)
Module 4 – Nonclinical Study Reports (Literature-Based)
Module 5 – Clinical Study Reports (Literature-Based)