- Manufacturers of pharmaceutical substances
- Distributors of pharmaceutical substances
To whom?
- Optimization of the company's financial costs when entering the market
- Rationalization of the company's time costs
- Assistance in case of difficulties during the registration procedures
- Supervision of the process of interaction with official authorized bodies
For what?
Entry of pharmaceutical substances into the Register
- Initial assessment of documents and information provided by the company for the formation of the registration dossier
- Development of a strategy for conducting registration procedures
- Preparation of the registration dossier for submission to the authorized regulatory bodies of the Russian Federation and the EAEU countries
- Preparation of documents in strict accordance with current legal requirements
- Assistance in organizing the payment of state duties of the Russian Federation and the EAEU countries for foreign companies
- Assistance in technical translation of registration dossier materials
- Assistance in notarization of documents on the territory of the Russian Federation
- Submission of the registration dossier to the authorized regulatory body of the Russian Federation and the EAEU countries
- Accompanying the process in the expert body
- Informing the client about the progress of the process of entering into the State Register of the pharmaceutical substance
- Timely completion of materials upon requests from the authorized regulatory bodies
- Receipt of the final registration documents by our experts in the authorized regulatory bodies of the Russian Federation and transfer of documents to the company
Procedure algorithm:
