Pharmacovigilance services

pharmacovigilance services for HUMAN and Veterinary Medicines AND vigilance serviceS FOR MEDICAL DEVICES

Medfiles is committed to ensuring the health and well-being of patients and consumers and to collaborating with clients to meet the increasingly complex regulatory requirements within the global pharmacovigilance landscape. We are specialised in pharmacovigilance and vigilance services concerning human and veterinary medicinal products and medical devices. Whether you need help at headquarters or local level, our experts are happy to help.

We will guide you through the entire product lifecycle, from safety profiling in the clinical phase to post-market PV systems. Our pharmacovigilance services are integrated with our medical information, regulatory affairs and clinical trial services, which means that you can benefit from our efficient multi-disciplinary teamwork in all tasks outsourced to us. Our services are always tailored to your needs, from comprehensive service packages to individual ad hoc tasks.

Pharmacovigilance throughout the product life cycle

Pharmacovigilance throughout the product life cycle

The Medfiles Pharmacovigilance Team of safety experts and safety physicians consists of skilled professionals in Europe and the US. By choosing to work with us, you can be sure that your pharmacovigilance system is always compliant and all the applicable requirements are met. To ensure the high quality of our services, our experts undergo continuous training and are always up to date with the latest requirements and practices.

Pharmacovigilance and vigilance services

EU QPPV, local QPPV and named safety contact

QPPV team with extensive experience in PV systems.

Human post-authorisation pharmacovigilance

Comprehensive up-to-date PV systems for human medicines.

ICSR
case processing

Triage, data entry, medical evaluation and expedited reporting.

Vet post-authorisation pharmacovigilance

Comprehensive up-to-date PV systems for veterinary medicines.

Clinical trial safety

Monitoring product safety during the clinical development phase ensures safe products on the market.

Medical device and IVD vigilance

Extensive experience and know-how of the Medfiles Vigilance and MD Team at your service.

Medical information

Efficient team with in-depth understanding of adverse events (AEs) and product quality complaints (PQC).

Geographical presence of pharmacovigilance and vigilance services

Geographical presence of pharmacovigilance and vigilance services

Over 20 years of experience in pharmacovigilance

65+

clients in 15 countries (eu, usa, asia)

6000+

Medicinal products monitored

4000+

Medical enquiries

150+

Aggregate reports

Free WEBINAR: EU Veterinary Medicinal Products Regulation from the perspective of variations and the quality part of the pharmacovigilance system

In our live webinar on 9 April, 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.

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