Vigilance  Our Services - QbD Group

Phamacovigilance Services

QbD Group understands that safety is paramount in a world of strict compliance. Our integrated approach combines flexible outsourcing models, strong governance, and high-quality safety reporting to support global operations while meeting local requirements effectively.

Whether you’re establishing PV for the first time, expanding into new territories, or optimizing existing processes, our team brings deep regulatory insight, practical experience, and flexible engagement models to safeguard patients and advance your business.

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End-to-end Services

From adverse event reporting and risk management to medical information we deliver end-to-end PV services that ensure compliance while safeguarding patient safety.

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Scalability Experts

Cost-effective streamlined solutions designed to scale with growing needs, ensure compliance and avoid the burden of building large internal structures.

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Global and Local Expertise

Operating effectively across both global and local settings, ensuring consistent compliance, operational efficiency, and seamless coordination across all regulatory environments

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Integrated Pharma Capabilities

We combine Regulatory Affairs, PV, Toxicology, QA , and Clinical expertise providing comprehensive support, broader insight, and more reliable outcomes

Efficiency & compliance: from global to local

At QbD Group, we offer end-to-end pharmacovigilance (PV) solutions that scale with your business - supporting both corporate headquarters and local affiliates with the same level of quality, flexibility, and compliance.

For headquarters:

  • Full ownership and responsibility of your PV system and safety obligations.
  • Expert support to successfully navigate the global regulations. 
  • Global project manager for strong project governance. 
  • Scalable approach for seamless adjustment of resources and cost control. 

 

For local affiliates:

  • Specialized guidance to operate confidently within the local regulatory landscape. 
  • Dedicated QPPV and expert liaison with regulatory bodies. 
  • In-country support to execute local PV activities. 
  • Alignment of HQ PV policies with local regulatory requirements at affiliate level. 
Vigilance Services  Our Services - QbD Group

A Partner for Sustainable Growth

At QbD Group, we support all pharmacovigilance setup models, from functional support to hybrid and full outsourcing designing proportionate frameworks that fit your current reality while remaining ready to expand as your portfolio, markets, and regulatory complexity increase.

 

Through modular delivery, flexible resourcing, and embedded governance, we ensure that your PV system remains compliant, efficient, and inspection-ready, allowing you to grow with confidence.

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Our offerings for Vigilance in

All
  • All
  • Pharma & Biotech
  • Medical Devices
  • In Vitro Diagnostics
QPPV / Local Representative

QPPV / Local Representative

Ensure global compliance with QbD's QPPV and Local Representative services. Gain expert support for safety oversight and regulatory obligations worldwide.
ICSR Management

ICSR Management

Maintain compliance and protect patient safety with QbD's expert management of individual case safety reports (ICSRs). Simplify safety reporting processes for clinical...
Pharmacovigilance & Certified Blended Training

Pharmacovigilance & Certified Blended Training

Empower your team with our certified pharmacovigilance training. Tailored courses to ensure compliance, mitigate risks, and enhance operational excellence.
Safety Reporting & Signal Detection

Safety Reporting & Signal Detection

Optimize your aggregate safety reporting with customized solutions from QbD. Manage risks, meet regulatory standards, and uphold patient safety with tailored strategies...
Regulatory Intelligence

Regulatory Intelligence

Stay ahead of evolving regulations with QbD’s regulatory intelligence services. Anticipate changes, address potential risks, and streamline compliance with informed,...
Pharmacovigilance QMS & Pharmacovigilance System Master File (PSMF)

Pharmacovigilance QMS & Pharmacovigilance System Master File (PSMF)

Streamline your pharmacovigilance compliance with QbD’s tailored QMS & PSMF services. Ensure efficiency, audit readiness, and global regulatory alignment.
Pharmacovigilance (PV) Audits

Pharmacovigilance (PV) Audits

Ensure compliance & inspection readiness with QbD’s certified PV audits, mock inspections, and ISO services. Strengthen your pharmacovigilance systems now.
Comprehensive Medical Information Services

Comprehensive Medical Information Services

Enhance patient safety and product trust with QbD Group's expert medical information services, ensuring timely, accurate responses and compliance throughout your product...
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Why QBD Group for Pharmacovigilance?

  • Scalable & Flexible Outsourcing Models

    We provide functional, hybrid, and full outsourcing options tailored to your business stage, workload, and strategic priorities — allowing you to grow without rebuilding systems.

  • Inspection-Ready by Design

    Our governance and readiness programs embed clarity, accountability, and traceability into your PV system — helping you stay inspection-ready at every stage of growth.

  • Deep Local & Global Expertise

    With integrated EU and UK regulatory knowledge, we help you manage both central oversight and local requirements across multiple jurisdictions — simplifying regulatory complexity.

  • Quality-Driven Safety Reporting

    From ICSRs to aggregate reports and signal management, we ensure consistency, accuracy, and regulatory alignment — supporting both compliance and regulatory confidence.

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+10 years of experience

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Full lifecycle support

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Global presence

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Best Managed Company

 

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Get in touch

Whether it’s pharmacovigilance, medical device vigilance, or tailored safety consulting, our experts are here to guide you through every step. Let’s work together to ensure the highest standards of safety and compliance for your products.
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Latest insights

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Webinar

Scaling Pharmacovigilance in Europe: A Practical Guide for Pharma SMEs and Biotechs

This webinar on demand will provide clear, experience-based guidance on how to manage pharmacovigilance (PV) across Europe without overextending your resources. You’ll learn how to balance global consistency with country-specific requirements, meet strict European timelines with lean teams, and apply practical, proven strategies that strengthen both central oversight and local execution.
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Webinar

Pharmacovigilance and Risk Management in Innovative Therapies: A Challenge in Drug Safety

Explore pharmacovigilance in cell, CAR T, and RNA therapies. Join our webinar to tackle tomorrow’s drug safety and risk management challenges.
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Webinar

Unlocking Strategic Value in Drug Safety for Life Sciences Organizations

Explore how drug safety teams can transform into proactive benefit drivers with the right tools & resources in this webinar on demand.
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Whitepaper

The One-Vigilance strategic roadmap to corporate excellence

This whitepaper introduces the concept of One Vigilance within the context of the current drug safety landscape. Download now.
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Whitepaper

Ensuring compliance and quality in Pharmacovigilance

The whitepaper emphasizes the importance of a robust pharmacovigilance QMS and a well-maintained Pharmacovigilance System Master File (PSMF). Download now.
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Case study

Optimizing pharmacovigilance for a biotechnology leader

Discover how QbD Group improved pharmacovigilance for a global leader in biotechnology, ensuring regulatory compliance and patient safety.
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Case study

Revolutionizing pharmacovigilance: a success story of strategic partnership and seamless integration

Discover how QbD Group's expert support enhanced a pharmaceutical company's pharmacovigilance, leading to a favorable inspection outcome by the local Regulatory Authority (AEMPS).
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Case study

Patient Support Program (PSP)

Learn about our patient support program (PSP) and how it helps manage customer support for a PV Spanish client. Resolve quality issues and ensure stability with QbD Pharma.