CTD Dossiers
PREPARE, REVIEW AND SUBMIT
Format: CTD Guideline (EU / 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)
