Registration of medicinal products

Preparation of registration dossier in national format
• Evaluation of dossier materials
• Development of regulatory documents, explanatory notes
• Development of SmPC/PIL
• Development of Mocks-ups
• Translation into Russian
• Formation of a complete registration dossier
 
Preparation of a registration dossier in the CTD format (according to the requirements of the EAEU)
• Transfer of dossiers from the national format to the CTD
• Development of Quality Overall Review, Non-clinical and Clinical Overviews
• Submission of dossier in .xml format