Preparation of CTD Dossiers for Products (Manufacturing/Importation/Exportation)

Our expert team shall prepare the MA Application Dossiers in e-CTD format in accordance with current regulations and guidelines, and then submit such MA Applications.

Determining missing dossiers (Gap Analysis)

Translation of necessary sections of the modules

Preparation of the application in e-CTD format, creating templates and submitting electronic entries for companies as requested by the Ministry of Health

Preparation of BA/BE dossiers, if applicable