NUVO provides complete service in writing, compiling and submission of ASEAN CTD (ACTD) dossiers, CTD Dossiers and country specific dossier for rest of the world.
- Dossier writing for Asia, Middle East, North Africa, and Greater Arabia, Central America
and the Caribbean, South America, Sub-
Saharan Africa, Australia and Oceania, European
countries not part of European Union as per their country specific formats.
- Dossier writing in CTD format as per countries requirement.
- Gap analysis and Conversion of Country specific dossier to CTD format.
- Dossier writing as per ASEAN CTD Guidelines for submission of ASEAN countries from Part I to IV.
- Summary writing for Part II, III, IV :
- Quality overall summary
- Clinical summaries
- Non-Clinical summaries
- Gap analysis and solutions for finalizing the Application.
- PSUR Writing
- Preparation of Part I as per country specific guidance.
- Conversion of CTD to ASEAN CTD
- Conversion of Country specific dossier to ASEAN CTD
- Query response assistance
- Preparation of SmPC and PIL
- Preparation of Mock ups