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
Translate »