pharmacovigilance services for HUMAN and Veterinary Medicines AND vigilance serviceS FOR MEDICAL DEVICES
Our Pharmacovigilance team consists of highly dedicated professionals with experience from the pharmaceutical and medical device industry and the CRO business. Our processes are fully compliant with local and EU regulations, guidelines and requirements. We are specialised in pharmacovigilance and vigilance services concerning human and veterinary medicinal products and medical devices and offer comprehensive services in the Nordic and Baltic countries, and through our regulatory network, also in other European countries. We will guide you through the entire product lifecycle, from safety profiling in the clinical phase to post-market PV systems. Our services are always tailor-made to your needs, from comprehensive service packages to individual and temporary tasks.
EU QPPV and local QPPV / named safety contact
Our QPPV team serves you with extensive experience in pharmacovigilance systems.
Post-marketing pharmacovigilance for human and veterinary medicinal products
Up-to-date and comprehensive PV systems for both veterinary and human products.
Pharmacovigilance agreements and audits
Medfiles ensures smooth processes between all stakeholders.
Clinical Trials Safety
Monitoring safety of the product during the clinical development phase is essential to ensure safe products on the market.
Medical Device Vigilance
Comprehensive experience and know-how of the Medfiles vigilance and MD team at your disposal.
Medical Information
Effective team with in-depth understanding of AEs and PQCs.
For more information please contact
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Heta Karvinen
MSc (Chemistry)
Director, Pharma Regulatory Affairs
heta.karvinen@medfiles.eu
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Satu Kujala
Head of Pharmacovigilance, EU QPPV
satu.kujala@medfiles.eu
