QPPV / Local Representative Services
Ensure seamless pharmacovigilance compliance across territories
Managing pharmacovigilance (PV) responsibilities across multiple regions can be complex and time-consuming. At QbD Vigilance, we provide Qualified Person for Pharmacovigilance (QPPV) and Local Representative services tailored to meet the specific regulatory needs of Marketing Authorization Holders (MAHs) in Europe, the UK, and beyond. With our expertise, you can ensure compliance while focusing on your core business objectives.
What are QPPV and Local Representative services?
The role of a QPPV (Qualified Person for Pharmacovigilance) is mandated under EU and UK regulations to oversee the safety of medicinal products. Additionally, certain countries require a Local Representative to manage pharmacovigilance activities at a local level. These roles ensure that MAHs remain compliant with region-specific PV obligations. Our key services include:
- EU QPPV services: Providing a central, qualified contact to oversee PV systems and ensure compliance within the European Union.
- UK QPPV services: Meeting the distinct requirements for pharmacovigilance oversight in the UK.
- Local PV representatives: Delivering region-specific PV support to ensure compliance in local markets.
- 24/7 availability: Ensuring around-the-clock support for adverse event reporting and regulatory queries.
- Audit and inspection readiness: Preparing your PV systems for audits and regulatory inspections.
Why are QPPV and Local Representatives essential?
A QPPV and Local PV Representatives play a critical role in ensuring product safety and maintaining compliance with international regulations. Here’s why they are indispensable:
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Regulatory requirement: Compliance with EU, UK, and global pharmacovigilance laws.
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Central oversight: Ensures all PV systems are monitored and managed effectively.
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Local expertise: Facilitates communication with local health authorities and stakeholders.
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Risk mitigation: Quick identification and resolution of safety issues to protect patients and products.
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Global reach: Seamless PV operations across multiple territories.
How can we help?
Dedicated EU and UK QPPV services
Local PV representation
Local PV representation
Providing in-market expertise to address region-specific regulatory obligations.
24/7 adverse event management
24/7 adverse event management
Ensuring timely reporting and communication with health authorities.
Regulatory liaison
Regulatory liaison
Acting as the primary point of contact for PV authorities.
Inspection readiness
Inspection readiness
Preparing your organization for audits and inspections to ensure compliance.
Why partner with QbD Group?
Partnering with QbD Vigilance ensures:
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Global expertise: Extensive experience managing PV responsibilities across Europe, the UK, and other international markets.
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Regulatory compliance: Dedicated QPPVs and local representatives ensure full adherence to PV regulations.
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Tailored solutions: Customized support that meets the unique needs of your organization.
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Proven reliability: Trusted by MAHs worldwide for high-quality pharmacovigilance services.
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24/7 support: Around-the-clock availability for adverse event reporting and regulatory inquiries.