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Vigilance  Our Services - QbD Group

Safety matters

QbD Group understands that safety is paramount in a world of strict compliance. Addressing the challenges of pharmacovigilance and post-market surveillance requires a dedicated approach. From adverse event reporting to risk mitigation, we ensure safety and compliance remain your top priority.
 
With comprehensive vigilance services and a global network of experts, we enable efficiency and precision while maintaining full compliance with the latest regulations. Trust us to handle the details so you can focus on innovation.

Integrated solutions for safety and information management

Our Vigilance solutions streamline the collection, management, and analysis of safety information. With a proactive approach, we help you meet global pharmacovigilance requirements.

Comprehensive end-to-end pharmacovigilance services

From adverse event reporting to risk management, QbD Group delivers complete solutions that ensure your products meet compliance standards while safeguarding patient safety.

Proven experience and GLOCAL expertise

With local and international insights, our team brings a unique blend of expertise to navigate complex regulatory environments.

24/7 support with competitive pricing

QbD Group provides reliable, around-the-clock support at competitive rates, ensuring your vigilance processes run efficiently without compromising quality.

Market trends & challenges

Mid-size and generic companies face unique hurdles in the ever-evolving pharmacovigilance landscape.

Mid-size companies often need to balance accountability for pharmacovigilance activities with strategic priorities like managing affiliate networks, maintaining centralized operations, and safeguarding trust and reputation. Tackling these challenges requires comprehensive solutions that span tactical, compliance, and strategic support, especially for established brands, over-the-counter (OTC) products, and Pharma Plus offerings.

For generic companies, the focus shifts to cost control and minimizing the loss of value from full-time equivalents (FTEs). Key concerns include maintaining accountability in post-commercialization activities, ensuring compliance to mitigate high-risk volumes, and managing distribution networks. Additionally, decisions about centralizing operations or managing affiliates often demand careful planning to uphold market reputation and trust.

Both mid-size and generic companies are grappling with high costs, resource constraints, and the challenge of adapting quickly to new regulations. Streamlining processes, reducing time-to-market, and ensuring compliance under these pressures require strategic, customized solutions.

QbD Group’s vigilance services are designed to address these challenges head-on, offering tailored support to help businesses thrive in this complex environment.

Vigilance Services  Our Services - QbD Group

 

Our offerings for Vigilance in

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...
Tracking Adverse Drug Reactions

Tracking Adverse Drug Reactions

Monitor and address adverse drug reactions with precision. QbD Group’s safety database solutions support regulatory compliance while prioritizing operational...
Vigilance and Pharmacoviglance Hotline Services

Vigilance and Pharmacoviglance Hotline Services

Emergencies don’t sleep and neither does our support. The One Vigilance hotline is open 24/7 all year round.
EudraVigilance Medicinal Product Dictionary (XEVMPD)

EudraVigilance Medicinal Product Dictionary (XEVMPD)

Achieve XEVMPD compliance effortlessly with QbD's expertise. Simplify your regulatory submissions and maintain up-to-date safety profiles for consistent, safe medicinal...
Aggregate Safety Reporting

Aggregate Safety Reporting

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

Project Management

Coordinate pharmacovigilance projects seamlessly with QbD’s project management expertise. Drive safety goals, meet compliance requirements, and improve operational...
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,...
Strategic Planning

Strategic Planning

Align safety and business goals with QbD’s strategic planning services. Build a clear roadmap for compliance while maximizing value and operational efficiency for your...
Safety Signal Program

Safety Signal Program

Enhance patient safety with QbD Group’s Safety Signal Program. Detect risks early, ensure compliance, and build trust with proactive safety solutions.
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.
Certified PV Audits, Mock Inspections & Activities ISO

Certified PV Audits, Mock Inspections & Activities ISO

Ensure compliance & inspection readiness with QbD’s certified PV audits, mock inspections, and ISO services. Strengthen your pharmacovigilance systems now.
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.
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.
Literature Monitoring Search Solutions & Alerts and a Set of Medical Information Solutions

Literature Monitoring Search Solutions & Alerts and a Set of Medical Information Solutions

Stay compliant with QbD Group's Literature Monitoring Services. Detect safety signals, ensure timely reporting, and enhance your vigilance strategy.
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Why QbD Group?

QbD Group’s vigilance services are tailored to the life sciences industry, providing the expertise and support needed to maintain compliance and prioritize safety.

What makes us different?

  • Global expertise, local insights: Combining international standards with local market understanding.
  • End-to-end support: From ICSR management to post-market surveillance.
  • Innovative solutions: Leveraging the latest technologies for greater accuracy and efficiency.
  • Proactive approach: Always one step ahead of changing regulations.

Partner with QbD Group to streamline your vigilance processes and ensure compliance with ease.

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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

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.