31.Oct.2017

Marketing authorization renewal approved for an international company

In this project, OCT team was responsible for preparation of documents to introduce amendments to the marketing authorization for currently marketed product and provided full support for regulatory submission.

The proposed changes required a thorough examination and were successfully approved upon its completion.

Earlier this spring, OCT have also obtained a marketing authorization for a Japanese company. In that project, the team’s responsibility consisted in collecting and preparing dossier documents, importing of drug samples into Russia for pharmaceutical examination and providing a comprehensive support throughout the application submission period. Following the examination, the medicinal product was considered to be the reference drug for the Russian market.

OCT provides a full spectrum of services to assist pharmaceutical companies with state registration of drug products in Russia. The team assumes responsibility for all regulatory interactions, preparation of documents and provides full support for sponsors in all types of registration procedures. Preparation of the registration dossier normally takes about 2.5 months, while its submission and examination take 5.5 months with 3 additional months for delivery of the regulatory decision.

Our portfolio includes 12 projects with successfully completed registration process.