CTD - DOSSIERS

Manufacturer: Perfect Pharmaceutical Consultants
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City Pune
State Maharastra
Country India

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Product Description

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

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

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