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 :
    1. Quality overall summary
    2. Clinical summaries
    3. 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

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