Dossiers

Dossier is a document file which have technical and administrative information.

Dossier as per CTD / ASEAN CTD / non-CTD (country specific guideline)

The Common Technical Document is divided into five modules:

1. Administrative information and prescribing information
2. Common Technical Document summaries (Overview and summary of modules 3 to 5)
3. Quality
4. Nonclinical Study Reports (toxicology studies)
5. Clinical Study Reports (clinical studies)

Common Technical Document for ASEAN countries contains of four parts:

1. Administrative information
2. Quality
3. Nonclinical Study Reports
4. Clinical Study Reports

We offer these services for:- Asian, African and CIS markets

Our services:-

•    Advising on suitable regulatory strategy
•    suggesting the finest route to the market
•    sketch up project plans
•    Monitoring the project till product registration