The introduction should include the proprietary name, nonproprietary name or common name of the drug substance, company name, dosage forms, strengths, route of administration, and proposed indications.

The Quality Overall Summary (QOS) should provide a summary aligned with the scope and structure of the Body of Data in Module 3. It should not introduce any new information, data, or justifications that are not already included in Module 3 or other sections of the CTD. 

Read the full guidance on the Quality Module.