Архивы medicinal product authorization - Национальный научный центр Фармаконадзора

Composition of a registration dossier

Елена Матвеева2021-11-09T14:35:44+03:00

Our company can perform:- preparation of drug samples for evaluation during state registration,- writing sections 2,4-2,7 of the registration dossier,- amending the already submitted documents,- advising on the preparation of the dossier,- if necessary, to finalize the documents.At the time of submitting an application for state authorization of a medicinal product to the Ministry of [...]

Medicinal product authorization

2021-10-25T15:30:10+03:00

In order for a drug to enter the Russian market, it is required to go through several stages, the very first of which is an affirmative registration, or revision examination. The process involves checking your product by the state for safety, efficacy in relation to the indicated pharmacological properties. The end result is the issuance [...]