CTD Dossier
Review of Dossier- RA Docs Management Services 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.
RA Docs Management Services can help you prepare entire technical document for drug product registration in various countries all over the world.
RA Docs Provides following consulting service in regards to Technical Document
Dossier Compilation and writing as per CTD Format – Common Technical Document
- Module 1 – Administrative Information
- Module 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.
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.