Services
Common technical document - ctd format
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CTD - Dossiers
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
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Module 2 - CT Overview - Module 3 – Drug & Product Part /CMC
- Module 4 – Non Clinical
- Module 5 – Clinical
- 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.
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
