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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.

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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.

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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.

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