Pharmacovigilance

The main function of pharmacovigilance is to improve the treatment and safety of patients when using medications, which is only possible when comprehensive, reliable, high quality and objective information on safety and effectiveness of pharmaceutical products is available. Each applicant, when registering a pharmaceutical product in Ukraine, must implement and maintain a pharmacovigilance system with a quality system in addition to the state pharmacovigilance system, which necessarily ensures that the authorization documentation will be obtained.

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    We will help our Customer to develop his/her own pharmacovigilance system with the quality system in the life cycle of pharmaceutical products, and we will help to manage this system that will ensure its functioning in Ukraine, which is a compulsory condition for the circulation of pharmaceutical products. We will develop a master file of the pharmacovigilance system, SOPs, Risk Management Plan (RMP) and PSUR of the pharmaceutical product, or harmonize the documentation provided by the Customer with the legislation of Ukraine. We will monitor the data in order to identify new risks, as well as changes in the known risks, and benefit-risk profile of pharmaceutical products. We will audit your pharmacovigilance system and provide recommendations on corrective actions for discrepancies found.