31.Oct.2017

Renewal of marketing authorization approved for an international company

In this project, OCT team compiled a dossier for incorporation of amendments into the marketing authorization of a currently marketed product and provided full support for further regulatory submission.

Proposed amendments required a thorough examination, which ensured regulatory approval.

Earlier this spring, OCT obtained another marketing authorization for a Japanese company. In the project, team’s responsibilities were to collect documents for a dossier compilation, to import drug samples into Russia for pharmaceutical expertise and to provide a comprehensive support throughout the submission of application. The expertise concluded that the medicinal product was a reference drug for the Russian market.

OCT provides a full spectrum of services to assist pharmaceutical companies with drug registration in Russia. OCT team undertakes all regulatory interactions, preparation of documents and provides full support for sponsors in all types of registration procedures. Compilation of the registration dossier usually takes up to 2.5 months; while its submission and expertise take 5.5 months followed by 3 additional months for the regulatory decision to be delivered.

Our portfolio includes 12 successfully completed registration processes.