Pharmacovigilance
with Tekrolab
off your to-do list.
Is it OK to outsource pharmacovigilance? |
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Pharmacovigilance is complex and continuosly evolving. Establishment and maintanance of pharmacovigilance system requires experience and expertise. So yes, outsourcing your pharmacovigilance duties on Tekrolab enables you to save time and resources for your core activities, ensuring full compliance with regulatory requirements.
Do I have to outsource full pharmacovigilance system? |
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How will our cooperation work? |
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How can Tekrolab help me with pharmacovigilance? |
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Tekrolab ensures EU based qualified person for pharmacovigilance (QPPV). We establish and maintain complete pharmacovigilance system and also prepare regular update of Pharmacovigilance System Master File (PSMF). We will walk your company through the EU databases (SPOR, IRIS, EUdravig… Datawarehouse, EVVET). Our specialists set up your products into databases, manage adverse events recording, reporting and documentation and monitor benefit-risk balance of your veterinary medicinal products. Training in pharmacovigilance and audits of pharmacovigilance system is matter of course.
Why should I choose Tekrolab? |
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We are staying up to date in this evolving regulatory environment. Our expertise means we have extensive knowledge and experience in monitoring and assessing the safety of veterinary medicines. Expertise allows us to effectively identify, evaluate, and manage any potential adverse event or side effect related to animal medication. Well defined processes and quality control mechanisms ensure compliance with regulatory requirements. We work closely with our clients to establish strong partnerships, continuously supporting and guidaning them throughout the pharmacovigilance process.
Are you interested?
Contact us to get more information: