Medicinal Product Registration
We provide full-cycle registration of medicinal products in compliance with national and EAEU requirements
Steps of the Registration Procedure
Preliminary Assessment and Consultation
- Calculation of registration costs
- Contract agreement
Dossier Preparation
- Collection of the registration dossier according to the approved list of documents
- Translation of all dossier documents into Russian and Kazakh
- Submission of the application for medical device examination to the NCLSC
- Transfer of the complete dossier package and samples to the NCLSC
Examination and Inspection
- Initial examination
- Specialized examination
- Inspection of the manufacturing site (if required)
- Laboratory testing
- Safety assessment
Issuance of the Registration Certificate
Additional Services
Pharmacovigilance / Pharmacovigilance Contact Person
User Testing
Conversion of Dossier into XML Format
Preparation of Documents and Organization of GMP / EAEU GMP Inspections
Get a Quote
