Common technical document - ctd format


CTD - Dossiers

CTD Dossier - Review of Dossier- Perfect Pharmaceutical Consultants Common Technical Document( Product Dossier) is an integral Part of any registration application for Marketing Authorization. Dossier in CTD Format/ ACTD Format or local country format  is submitted to Food & Drug Authority or Ministry of health or any other equivalent authority along with other required technical documents and legal manufacturing permissions.

Perfect Pharmaceutical Consultants can help you prepare entire technical document for drug product registration in various countries all over the world.

PPC Provides following consulting service in regards to Technical Document

  • Dossier Compilation and writing as per CTD Format – Common Technical Document
    • Module 1 – Administrative Information
    • Common Technical DocumentModule 2 - CT Overview
    • Module 3 – Drug & Product Part /CMC
    • Module 4 – Non Clinical
    • Module 5 – Clinical
    CTD Format Dossier is widely used in semi regulated & regulated market like CIS Countries, Middle Eastern countries, European Union, USA , Australia , Canada, Japan, etc

  • 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.Pharma Consulting - Technical Document
    ACTD Format is Asian harmonization for Common Technical Document used in Asian Countries like Vietnam, Thailand, Singapore, and Malaysia etc

We can help you compile and write entire technical document or specify modules as per your request, we also help companies establish their Document Management and technical writing system by guiding them with draft templates on BMR , COA , MOA , and other technical documents. We customize the same as per company requirement – Good for startup companies or scale up companies.

Why work with us???

  • Over 20 Years of Industry Experience
  • Well Qualified Team
  • Have compiled more than 400 ACTD & CTD Dossiers for various Pharmaceutical Companies