As Ukraine transitions to MDR and IVDR, the government aims to use European electronic systems rather than developing its own. This approach seems reasonable, but is it feasible? One of the key innovations of MDR and IVDR is the Unique Device Identification (UDI) system and the EUDAMED electronic database. In Ukraine, the regulation of medical […]
On 27th June, 2018, an external audit of pharmacovigilance processes in Cratia Ltd has been conducted by Ferrer International.
“Cratia Ltd” provides pharmacovigilance processes in Ukraine for variety of national and foreign pharmaceutical companies.
In June 2018, “Ferrer”, an international medical product manufacturer, conducted GVP audit of processes that are being carried out for this company by “Cratia Ltd” in Ukraine.
During the audit, it was confirmed that all pharmacovigilance processes for which “Cratia Ltd” is responsible are conducted in accordance with the requirements of European and Ukrainian legislation and in accordance with the signed Safety Data Exchange Agreement between our companies. Also, there were no critical findings during the audit, all other findings and recommendations were closed in prompt manner according to a CAPA-plan developed in collaboration.
Thus, the pharmacovigilance processes that provide “Cratia Ltd” in Ukraine for their partners are in compliance with the requirements of Ukrainian and European legislation, as well as the requirements of the Customer company.
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