regulatory affairs and pharmacovigilance services for veterinary medicines
Bringing veterinary medicines to market – and keeping them there – requires a deep understanding of regulatory requirements and processes. The Medfiles veterinary team can support you from regulatory strategy, marketing authorisation application and pharmacovigilance system set-up to marketing authorisation maintenance and post-authorisation pharmacovigilance activities. We offer flexible solutions for companies of all sizes – from individual tasks to fully outsourced service models.
Ready for the EU market? GO/NO-GO assessment for veterinary medicinal products
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 – covering regulatory strategy, dossier readiness evaluation and pharmacovigilance obligations.
We identify your regulatory and pharmacovigilance gaps early, recommend the most suitable EU procedure, and set out a realistic roadmap to market – so you commit resources with confidence, not guesswork.
Regulatory affairs services for veterinary medicines
We can support you throughout the marketing authorisation process for veterinary medicines in the EU and UK. With over 10 years’ experience in regulatory submissions, veterinary legislation and regulatory procedures, our team will ensure a smooth and compliant process.
Our services include product classification, regulatory strategy planning, preparation and submission of marketing authorisation dossiers, preparation and updating of product information, review of packaging and maintenance of marketing authorisations. You can outsource individual tasks or the entire regulatory process.
Pharmacovigilance services for veterinary medicines
We provide pharmacovigilance support at both EU and UK. With over 15 years’ 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.
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.
Whether you need help with a specific task or a more comprehensive service package, we’re here to help. We also work closely with our Feed team, which provides services for the development, regulation and marketing of feed and feed additives. This allows you to benefit from our extensive animal health expertise.
Free WEBINAR: EU Veterinary Medicinal Products Regulation from the perspective of variations and the quality part of the pharmacovigilance system
In our webinar you will learn about the main changes and requirements brought about by the Veterinary Medicinal Products Regulation. In the webinar we will discuss variation management and the relationship between pharmacovigilance systems and the related quality measures.
Over 10 years of experience in veterinary regulatory affairs & pharmacovigilance
90+
clients in 20 countries (eu, usa, asia)
200+
Global and local regulatory responsibilities for veterinary products
95+
Marketing authorisations granted in Europe (CP, DCP, MRP, NP)
6000+
Medicinal products monitored
“Medfiles’ personnel have always been very approachable, respectful, with full availability independently of the season of the year and always happy to help and assist. Thanks to good cooperation and experiences, we have been a satisfied client for many years. Our partnership with Medfiles remains a cornerstone of our success, enabling us to deliver innovative and effective solutions to the animal health market.”
– Bimeda
“Medfiles’ independent way of working work is an advantage for us. And such a large pool of professionals can provide the right expertise for every need. – – We always felt secure in knowing the process was moving forward, as Medfiles’ experts kept us well informed. Any questions we had were answered promptly. Our cooperation was reliable and professional at all times.”
– Vetcare
insights into veterinary medicines
Our expert team regularly writes blogs on veterinary medicines, covering topics such as trends in animal health, the repurposing of human medicines for veterinary use, and the Veterinary Medicines Regulation (EU) 2019/6.
Contact us
You may also be interested in:
- Free webinar: EU Veterinary Medicinal Products Regulation from the perspective of variations and the quality part of the pharmacovigilance system
- Meet Medfiles’ dedicated animal health team
- Bimeda & Medfiles: Partnership in veterinary regulatory affairs in the EU
- Vetcare & Medfiles: Working together on the maintenance of marketing authorisations and pharmacovigilance of veterinary medicines
- Meet our people: Veterinarian brings valuable expertise to veterinary pharmacovigilance