QPPV / Local representative
At QbD Group, we understand the complexities of managing Pharmacovigilance (PV) responsibilities across multiple territories. Whether you are an MAH in Europe, the UK, or globally, our services cater to your specific needs.
Don’t hesitate to contact us for more information.
How we can help you?
QPPV and Deputy Services:
Designation of QPPV and deputy for EU/UK/local compliance.
Personal responsibility for safety oversight and compliance.
Pharmacovigilance System Management:
Establishment and maintenance of the company’s pharmacovigilance system.
Comprehensive management for regulatory adherence.
 Safety Monitoring:
Ongoing monitoring of safety profiles for company drugs.
Proactive identification and management of emerging safety concerns.
 24-Hour Health Authority Contact:
Single contact point for Health Authorities, ensuring 24/7 availability.
Prompt and effective communication for regulatory matters.
Why it is important?​
Patient Safety:
Centralizing the QPPV system in the EU or country of operation emphasizes QbD’s commitment to patient safety, ensuring efficient and prompt response to any safety concerns.
Regulatory Adherence:
Meeting the EU and UK regulatory requirements for QPPV presence demonstrates QbD’s dedication to strict adherence to pharmacovigilance standards and regulations.
Efficiency and Solvency:
Centralizing the QPPV system enhances the efficiency and solvency of pharmacovigilance activities, ensuring the continuous and reliable management of the quality and safety profile of pharmaceutical products.
Why QbD Group?
With more than 10 years providing PV services, our experience ensures optimal compliance with national and international PV regulations. Following our commitment to quality, our PV activities are certified to ISO 9001:2015.
- Compliance Assurance.
- Quality System Influence.
- Continuous Availability.
- Expert Support in Absence.
- Post-Brexit Compliance.
- Local Presence in Spain.
Tailored solutions
The actual approach of this service is up to you. It is fully tailored to your needs.
Contact us
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.
