QPPV Services
Qualified person responsible for pharmacovigilance (QPPV) services contribute significantly to the overall effectiveness of pharmacovigilance efforts, fostering trust in the pharmaceutical industry and prioritizing the well-being of patients. Qinecsa QPPV services provide expert pharmacovigilance leadership to ensure regulatory compliance, uphold quality standards, and safeguard patient safety in the pharmaceutical industry.
Local and Global QPPV Expertise
At Qinecsa, pharmacovigilance is a critical component of patient safety in the pharmaceutical industry. Our Qualified Person for Pharmacovigilance (QPPV) services provide all-inclusive support to ensure you meet country-specific regulatory requirements. Our team of experienced specialists have access to a network of PV experts and QPPVs across the UK, EU, and broader global regions. We maintain thorough knowledge of current pharmacovigilance legislation and engage with regulatory authorities to stay ahead of changing requirements. This approach also leads to seamless compliance regardless of where your products are marketed. Our services include:
- Development and maintenance of pharmacovigilance systems
- Regular auditing and quality assurance of safety processes
- Management of safety databases and signal detection
- Coordination with regulatory authorities during inspections
- Training for your team on pharmacovigilance best practices
Tailored Solutions for Organisational Needs
Whether you’re a small biotech firm or an established pharmaceutical company, we customise our QPPV services to align with your specific needs. Our flexible services and solutions include:
- Outsourced QPPV functions for companies without in-house capabilities
- Supplementary support for existing pharmacovigilance teams
- Interim QPPV coverage during transitions or staff shortages
- Advisory services for companies establishing their own QPPV functions
We work with a network of PV experts that serve as QPPV / LPPV for global and local pharma and biotech firms globablly.
EU QPPV / UK QPPV
Extensive network of QPPVs in the EU and UK with the required level of experience, qualification, and registration with Eudravigilance.
LPPV
Support available from the local person for pharmacovigilance in several countries in the EU to help navigate through the compliance requirement of country specific regulations.
Back-up Arrangement
Availability of a back-up/deputy to the QPPV and access for the QPPV/deputy to a medically qualified person at all times.
Working with Qinecsa for Your Needs
With support from Qinecsa, you benefit from our combined experience across multiple therapeutic areas and regulatory environments, ensuring your activities are managed with the highest level of competence and compliance. As regulations evolve, our hands-on approach means we anticipate changes and adapt your processes as needed, thus minimising disruptions and maintaining continuous compliance.
