Vital For Market Authorization
The Common Technical Document (CTD) Dossier is crucial in registration applications for Marketing Authorization. It serves as a standardized format for submitting essential information to regulatory authorities like the Food & Drug Authority, Ministry of Health, or equivalent bodies. It ensures that all necessary technical documents and legal manufacturing permissions are included, facilitating the approval process for drug products worldwide.
Trusted Expertise
Across Borders
Dossier Compilation as per CTD Format (Common Technical Document):
- Module 1: Administrative Information
- Module 2: CT Overview
- Module 3: Drug & Product Part / CMC (Chemistry, Manufacturing, and Controls)
- Module 4: Non-Clinical Study Reports
- Module 5: Clinical Study Reports
The CTD format is widely used in semi-regulated and regulated markets such as CIS Countries, Middle Eastern countries, European Union, USA, Australia, Canada, and Japan.
Dossier Writing and Compilation as per ACTD Format (Asian Common Technical Document):
- Part I: Administrative Documents
- Part II: Quality Documents
- Part III: Non-Clinical Documents
- Part IV: Clinical Documents
ACTD Format is Asian harmonization for Common Technical Document used in Asian Countries like Vietnam, Thailand, Singapore, and Malaysia.
Professional Custom
Document Management
