Services:
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Writing SOP (Standard Operating Procedures) with templates, logs and forms thereto necessary for functioning of pharmacovigilance and quality department;
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Writing the Master File of the Pharmacovigilance System;
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Personnel trainings for the customer company;
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Writing PSURs (Periodic safety update reports);
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Writing DSURS (Development safety update reports);
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Audit of the pharmacovigilance system with a report and CAPA preparation (Corrective and Preventive Actions);
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Audit of the quality system with a report and CAPA preparation (Corrective and Preventive Actions);
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Monitoring of medical scientific literature and sites of regulatory bodies;
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Obtaining, handling and work with Individual Safety Reports;
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Management of safety signals;
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Consulting on pharmacovigilance and quality;
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Collection and analysis of adverse events in CT;
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Writing Risk Management Reports;
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Handling drug quality complaints;
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Transfer of ADRs to regulatory bodies;
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Medical expertise of safety cases;