Monitoring of the efficiency and safety of drug products in circulation on the territory of the Russian Federation.
Since 2016, the holder or owner of marketing authorization of drug product in circulation in the Russian Federation performs monitoring of drug products efficiency and safety and provides in accordance with the procedure established to the correspondent authorized federal executive authority (Roszdravnadzor) the information on side effects, adverse effects, serious adverse drug reactions, unexpected adverse reactions when applying drug products, on idiosyncrasy, failure response and also on other effects and circumstances, constituting a threat for human life or threat when applying drug products and identified at all stages of circulation of drug products in the Russian Federation and other countries.
Our company provides highly professional pharmacovigilance services allowing us to follow the rules of good pharmacovigilance practice and save the budget.
The full range of services in the field of pharmacovigilance is carried out from the preparation of single notification up to the performance of full work in the sphere of pharmacovigilance including: analysis of current documentation, development or bringing the documentation in accordance with the requirements of legislation; development of standard operational procedures; development and implementation of security measures; permanent drug security control at the market; reporting on cases of adverse effects and reactions; preparation of PSUR; performance of trainings and seminars on pharmacovigilance.
If you need more detailed information on all cooperation-related issues you may dial (499) 110-55-10 or use the feedback form on our website.