{"id":8169,"date":"2021-11-12T10:58:55","date_gmt":"2021-11-12T08:58:55","guid":{"rendered":"https:\/\/medfilesgroup.com\/our-services\/pharmacovigilance-vigilance-service%e2%80%8b\/pharmacovigilance-agreements-and-audits\/"},"modified":"2026-09-24T12:47:43","modified_gmt":"2026-09-24T09:47:43","slug":"pharmacovigilance-services-for-veterinary-medicinal-products","status":"publish","type":"page","link":"https:\/\/medfilesgroup.com\/ja\/%e5%8b%95%e7%89%a9%e7%94%a8%e5%8c%bb%e8%96%ac%e5%93%81%e3%81%ae%e3%81%9f%e3%82%81%e3%81%ae%e8%96%ac%e4%ba%8b%e3%82%b5%e3%83%bc%e3%83%93%e3%82%b9%e3%81%8a%e3%82%88%e3%81%b3%e5%ae%89%e5%85%a8%e6%80%a7\/pharmacovigilance-services-for-veterinary-medicinal-products\/","title":{"rendered":"Post-authorisation pharmacovigilance services for veterinary medicinal products"},"content":{"rendered":"\n
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Post-authorisation pharmacovigilance services for veterinary medicinal products<\/h1>\n\n\n\n

Medfiles provides pharmacovigilance services for veterinary medicinal products in both the EU and the UK. With over 15 years\u2019 experience in veterinary pharmacovigilance and PV system set-up, our team will help you to meet your obligations efficiently and in line with regulatory expectations.<\/p>\n\n\n\n

Our services include e.g. adverse event processing and reporting, signal detection, pharmacovigilance system set up and maintenance, veterinary QPPV service and support with quality management system related to pharmacovigilance. We offer both fully outsourced solutions and flexible support tailored to your needs.<\/p>\n\n\n\n

In addition to pharmacovigilance support, we offer veterinary regulatory affairs<\/a> and feed regulatory services<\/a>.<\/p>\n\n\n\n

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Ready for the EU market? <\/strong>GO\/NO-GO assessment for veterinary medicinal products<\/h2>\n\n\n\n

Before committing significant resources to dossier preparation, clinical studies or pharmacovigilance system set-up, it pays to know exactly what lies ahead. Our fixed-fee GO\/NO-GO assessment gives pharmaceutical companies, animal health start-ups and non-EU marketing authorisation holders a clear, practical assessment of what is needed for successful EU marketing authorisation <\/strong>\u2013 covering regulatory strategy, dossier readiness evaluation and pharmacovigilance obligations.<\/p>\n\n\n\n

We identify your regulatory and pharmacovigilance gaps early, recommend the most suitable EU procedure, and set out a realistic roadmap to market \u2013 so you commit resources with confidence, not guesswork.<\/p>\n\n\n\n

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Read about pharmacovigilance services for veterinary medicinal products<\/h2>\n\n\n\n
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Pharmacovigilance system set-up and maintenance<\/h2>\n\n\n\n

With the help of Medfiles\u2019 experienced Pharmacovigilance Team, you can set up your veterinary pharmacovigilance system in the EU or improve your existing system. We will find the ideal solutions for your company and your product\u2019s safety profile, in line with the current pharmacovigilance requirements. <\/p>\n\n\n\n

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Our experts will assist you in determining the necessary internal and external communication channels and responsibilities of stakeholders related to your product\u2019s safety and animal welfare.<\/p>\n\n\n\n

Medfiles can create and maintain your pharmacovigilance system master file (PSMF) and ensure that your PV system remains fully compliant with the applicable EU and UK regulations and guidelines, to be inspection-ready at all times.<\/p>\n\n\n\n

Medfiles has its own full PV and quality system in place, and our experts can prepare and review standard operating procedures (SOPs) and other quality-controlled operating instructions needed for creating a pharmacovigilance system or improving an existing system. If you need a comprehensive pharmacovigilance systems for your veterinary products, you can rely on our expertise.<\/p>\n\n\n\n

See also:<\/strong><\/p>\n\n\n\n