Drug Registration in Russia and the EAEU

OCT provides a full range of services for the marketing authorization of medicines in Russia and EAEU countries, for both local and International Sponsors.

• Validation of the sponsor's dossier and gap analysis. Development of drugs/APIs registration strategy.
• Preparation of registration dossiers in eCTD format.
• eCTD dossier conversion into XML.
• Development of EAEU eCTD Module 2 (Sections 2.3–2.7).
• Normative document development in acc. with EAEU requirements or local legislation.
• Development of Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)/Instructions for medical use.
• Conducting PIL user testing.
• Development of packaging mockups.
• Arrangement of sample import for pharmaceutical examination.
• Organization of the comparative dissolution kinetics test.
• Translation, revision, and notary certification of all necessary documentation.
• GMP inspection.
• Pharmacovigilance.
• Organization and conducting of local pre-clinical and clinical studies required for drug registration.
• Registration and re-registration of the maximum-selling price.