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Europe & UK-Based Pharmacovigilance (PV) Services

At Viginovix, we understand that pharmacovigilance (PV) compliance in Europe and the UK comes with its own set of unique challenges. With evolving regulatory landscapes, strict reporting requirements, and complex safety obligations, pharmaceutical companies need a trusted partner to navigate the intricacies of EU & UK pharmacovigilance with confidence.

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Whether you’re an established pharmaceutical company, a biotech startup, or a marketing authorization holder (MAH), our specialized Europe/UK-based services ensure that your drug safety operations remain compliant, efficient, and future-ready. From QPPV support to PSMF maintenance, we take care of the heavy lifting—so you can focus on delivering safe and effective treatments to patients.

Our Risk & Signal Management Services

            PV Audit-as-a-Service: Ensuring Compliance, Minimizing Risks

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Regulatory authorities in Europe and the UK demand strict adherence to Good Pharmacovigilance Practices (GVP). Non-compliance can lead to serious consequences, including penalties, product recalls, or loss of market authorization. Our PV Audit-as-a-Service provides independent, expert-led evaluations to identify gaps and ensure that your pharmacovigilance system is robust and audit-ready at all times.

 

  • Comprehensive audits covering all PV activities, including case management, signal detection, and risk management

  • Mock inspections to help prepare for MHRA and EMA regulatory audits

  • GVP compliance checks tailored to your company’s size and structure

  • Detailed corrective and preventive action (CAPA) plans for seamless compliance

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"Regulatory compliance isn’t just about passing audits—it’s about maintaining patient trust and product integrity. We make sure your PV system is always inspection-ready."

            QPPV Services: Trusted Expertise for Your European & UK Market Presence

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If your company is marketing pharmaceuticals in the European Economic Area (EEA) or the UK, you are required to appoint a Qualified Person for Pharmacovigilance (QPPV) to oversee drug safety operations. Our highly experienced, EEA and UK-based QPPVs provide end-to-end pharmacovigilance oversight, ensuring that your safety processes align with EU-GVP Module I requirements and MHRA guidelines.​

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  • **Serving as your legally mandated QPPV in the EEA and/or UK

  • 24/7 availability for regulatory authority interactions and crisis management

  • Oversight of risk management plans (RMPs) and periodic safety reports (PSURs, PBRERs, DSURs)

  • Signal detection, benefit-risk analysis, and proactive risk minimization strategies

  • Seamless coordination with affiliates, partners, and global safety teams​​

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"Your QPPV is more than just a regulatory requirement—it’s your frontline defense in ensuring drug safety. At Viginovix, our experts bring experience, reliability, and regulatory insight to safeguard your products."

            EudraVigilance Setup & Maintenance: Streamlining Safety Reporting

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EudraVigilance is the cornerstone of drug safety reporting in Europe. Pharmaceutical companies must ensure their Individual Case Safety Reports (ICSRs) are accurately submitted to EMA’s EudraVigilance system in compliance with EU regulations. Setting up and maintaining an effective EudraVigilance system can be complex, but we make it simple.

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  • End-to-end EudraVigilance registration, including EMA user access and XEVMPD setup

  • Configuration of automated ICSR submissions for expedited reporting

  • Ongoing system updates and maintenance to align with EMA’s evolving requirements

  • Training for your PV teams to ensure effective use of the system

  • Quality control and validation of ICSR transmissions to avoid compliance errors

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"Handling EudraVigilance submissions shouldn’t slow you down. We ensure smooth, compliant reporting—so you stay ahead of regulatory obligations."

            PSMF Setup & Maintenance: Your Essential Pharmacovigilance Blueprint

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The Pharmacovigilance System Master File (PSMF) is a critical regulatory document required by EU-GVP and MHRA for companies marketing medicinal products in Europe and the UK. It provides a complete overview of your pharmacovigilance system—and must be kept up to date at all times. At Viginovix, we help companies set up, maintain, and continuously improve their PSMFs to meet the latest regulatory standards.

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  • Complete PSMF creation tailored to your company’s PV framework

  • Regular updates to reflect system changes, new risk management measures, and audit findings

  • Integration with your QPPV for seamless compliance management

  • Gap analysis and remediation strategies to ensure regulatory alignment

  • Ongoing PSMF maintenance, version control, and submission readiness

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"A well-maintained PSMF isn’t just a document—it’s your company’s pharmacovigilance roadmap. We make sure it’s clear, compliant, and always up to date."

Why Choose Viginovix for Europe & UK-Based PV Services?

Deep Regulatory Expertise – Our team stays ahead of the latest EMA, MHRA, and EU-GVP regulations to ensure your compliance.​

End-to-End Support – From QPPV oversight to audit preparation, we cover all aspects of pharmacovigilance in Europe and the UK.

Technology-Driven Solutions – We integrate technology, Analytics, and compliance tracking to enhance efficiency.

24/7 Regulatory Readiness – Our experts are available around the clock to manage urgent safety issues and regulatory requests.

Scalable Services – Whether you need a single service or full-suite pharmacovigilance support, we tailor our solutions to your business needs.

"Navigating pharmacovigilance requirements in Europe and the UK can be challenging—but with Viginovix, you don’t have to do it alone. Our expertise, technology, and commitment to patient safety make us the ideal partner for your drug safety needs."

Get in touch today to learn how Viginovix can support your Europe & UK pharmacovigilance strategy.

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