Preparation of the registration dossier in the national format

• Evaluation of dossier materials
• Development of RD, explanatory note
• Development of instructions for medical use
• Development of graphic design layouts for packaging
• Translation of dossier materials into Russian
• Formation of a complete registration dossier

Preparation of registration dossier in CTD format (according to the requirements of the EAEU)

• Translation of dossier from national format to OTD
• Writing quality reviews, non-clinical review, clinical review
• Submitting dossier in .xml format

Registration process

• Submission for registration, concluding an agreement with the Center for Expertise and Testing in Healthcare (CEIZ)
• Support of dossier examination, responses to expert comments
• Conclusion of an agreement with the Laboratory of Pharmacopoeial and Pharmaceutical Analysis to carry out control of drug samples
• Import of standard samples
• Obtaining a registration certificate