TURNKEY REGISTRATION

Formation of a single market of drugs on the territory of the Eurasian Economic Union (EAEU) requires a unified approach to the requirements for registration dossier formation for approval of the drug for medical use.

There are two procedures for registering new drugs as required by the EAEU: Decentralized Procedure and Mutual Recognition Procedure.

X7 Research staff accompanies the whole process until the new registration certificate is obtained, performs registration dossier submission according to any procedure chosen by the customer, and the customer can choose the reference state for submission (Russia, Kazakhstan, Armenia, Belarus, Kyrgyzstan). Thanks to this the customer can expand geographical boundaries and choose the reference state convenient for him.

Our specialists also render services on gathering and submission of files for the procedures of amendments and reregistration.

DECENTRALIZED PROCEDURE

MUTUAL RECOGNITION PROCEDURE

PREPARATION OF DOSSIERS FOR CONVERSION TO XML FORMAT

FULL EAEU COMPLIANCE

MODIFICATION

RE-REGISTRATION

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