+7 (495) 225 9300
+7 (495) 644 0904

Drug Safety (Pharmacovigilance) Services

Collection of Drug Safety information using the local telephone line operating during business hours and 24/7 fax;

Processing of information received on side-effects and adverse reactions and forwarding it to the manufacturer within one working day;

Provision of all necessary documents on behalf of manufacturer on safety of the product(s) to the health care authorities of the Russian Federation for the purpose of maintenance of MA (state registration);

Adaptation of the documents, which have to be submitted to the Russian health care authorities (including PSUR and DDPS), according to local requirements;

Supporting manufacturer / MA-holder in answering the questions which may be raised by health care authorities of the Russian Federation concerning drug safety procedures.