• There are no suggestions because the search field is empty.
Search icon
Request audit
Contact us
Pharmacovigilance QMS and PSMF Services Vigilance - QbD Group

Pharmacovigilance QMS & PSMF Services

Streamline compliance with efficient pharmacovigilance systems

Ensuring compliance with national and international pharmacovigilance (PV) regulations requires robust systems and meticulous documentation. At QbD Group, we offer a comprehensive Pharmacovigilance Quality Management System (QMS) and support for your Pharmacovigilance System Master File (PSMF).

Whether your organization has no PV function or limited capabilities, our “bolt-on” solutions via PV agreements make it simple to achieve regulatory compliance.

Read more
Get in touch

What are pharmacovigilance QMS and PSMF?

A Pharmacovigilance QMS is a structured framework designed to ensure the effective management of PV activities in line with Good Pharmacovigilance Practice (GPvP) guidelines. The PSMF is a mandatory document that provides a detailed overview of the PV system for Marketing Authorization Holders (MAHs). Key features of our QMS and PSMF services:

  • QMS implementation: Establishing a quality management system tailored to your PV needs.

  • PSMF preparation and maintenance: Creating and updating your PSMF to ensure compliance with EMA, FDA, and other regulatory authorities.

  • Regulatory alignment: Ensuring your systems meet international GPvP standards.

  • Seamless integration: “Bolt-on” solutions via PV agreements to simplify implementation.

  • Continuous support: Ongoing maintenance and optimization of your QMS and PSMF.

Discover why QMS and PSMF are essential for pharmacovigilance
Pharmacovigilance QMS and PSMF Services Vigilance - QbD Group (1)

Why are QMS and PSMF essential for pharmacovigilance?

A robust QMS and a well-maintained PSMF are critical to achieving efficiency and compliance in pharmacovigilance operations. Here’s why they matter:

  • Regulatory compliance: Meet global requirements for PV system documentation and management.

  • Operational efficiency: Streamline processes to reduce administrative burdens.

  • Risk mitigation: Ensure accurate reporting and timely detection of safety signals.

  • Audit readiness: Maintain up-to-date documentation for inspections and audits.

  • Scalability: Adapt to evolving regulations and organizational needs.

Discover how we can support you

How can we help?

QbD Group provides tailored solutions to simplify your pharmacovigilance compliance needs:

Comprehensive QMS setup

Comprehensive QMS setup

Implementing a PV Quality Management System aligned with international standards.

PSMF development

PSMF development

Preparing detailed Pharmacovigilance System Master Files that meet EMA and FDA requirements.

Seamless “bolt-on” solutions

Seamless “bolt-on” solutions

Integrating QMS and PSMF services via pharmacovigilance agreements.

Ongoing maintenance

Ongoing maintenance

Regular updates to ensure documentation stays compliant and audit-ready.

Expert guidance

Expert guidance

Leveraging extensive experience in PV operations and regulatory compliance.

Pharmacovigilance QMS and PSMF Services Vigilance - QbD Group (2)

Why partner with QbD Group?

Choosing QbD Group for QMS and PSMF services provides:

  • Regulatory expertise: Decades of experience in pharmacovigilance compliance and system design.

  • Tailored solutions: Flexible services designed to meet your unique organizational needs.

  • Seamless integration: Simplified implementation of QMS and PSMF with minimal disruption.

  • Global reach: Expertise in meeting international and regional regulatory requirements.

  • Reliable support: Continuous assistance to keep your systems efficient and compliant.

Contact us
doc-mask

Related content

preview_image
Webinar

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

This live webinar 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.
Read More
preview_image
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.
Read More
preview_image
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.
Read More
preview_image
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.
Read More
preview_image
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.
Read More
preview_image
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.
Read More
preview_image
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).
Read More
preview_image
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.
Read More
Discover all
contact-mail

Get in touch

Looking for an efficient way to ensure compliance with pharmacovigilance regulations?

QbD Group provides comprehensive QMS and PSMF services to streamline your pharmacovigilance operations and maintain compliance with global standards. Contact us today to learn how we can help.

Vigilance_Get in touch