Regulatory Affairs Services

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

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