Service | ROW & ASEAN
NUVO provides complete service in writing, compiling and submission of ACTD and country specific
dossier for rest of the world. Backed with strong contacts in Russia and many more countries,
which helps in obtaining several successful approvals.
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 :
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.
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