Dossier is a file document submitted based on the requirement of the drug approval process. It is a comprehensive scientific document used to obtained worldwide licensing approval of a drug by diverse health authorities. There are different requirements in different countries for registration of a product. Regulatory agencies require Pharmaceutical Dossiers to gain approval to market drugs. Dossier is a document file which has technical and administrative information. Pharma companies prepare dossier as per CTD / ASEAN CTD / non-CTD (country specific guideline).CIS countries follow their own country specific dossier format.