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Pharmacovigilance services are intended for marketing authorisation holders (MAH) to monitor the safety of their veterinary medicinal products after the registration. Continuous monitoring and evaluation of the benefit-risk balance enables MAH to take appropriate and fast action if necessary.
Tekro has developed a pharmacovigilance system that is fully compliant with the applicable Regulations (EU) 2019/6 and (EU) 2021/1281 and that is being applied to its own products.
Complete Pharmacovigilance system – outsourced Pharmacovigilance solution
Preparation of Pharmacovigilance system master file (PSMF).
Services of Qualified Person responsible for Pharmacovigilance (QPPV).
Post-registration safety studies
Consultations and training in Pharmacovigilance
Benefit-risk balance assessment
Regular monitoring of current scientific literature and adverse events databases.
Signal management process (detection, prioritisation, validation, assessment and documentation of outcome)
Audit of Pharmacovigilance system
Administration of EMA on-line databases SPOR, EudraVigilance, IRIS etc.
If you have an internal Pharmacovigilance system and you only need help with some of its parts, we can assist you.
