Local pharmacovigilance
Local Drug Safety Solutions for Global Compliance
Local pharmacovigilance requires in-depth knowledge of regional regulatory frameworks, reporting requirements, and ongoing pharmacovigilance activities. Our dedicated team at Qinecsa understands how to navigate this complex landscape and its regulations across different regions.
This is why we provide custom, fully-managed solutions so your pharmacovigilance requirements meet local compliance standards. Rest assured, our expertise spans many therapeutic and product types, allowing us to provide comprehensive local support while maintaining consistency with your global operations.
Localised PV Services for Regional Requirements
Each region has unique pharmacovigilance challenges that may require specialised approaches. Our local partner network offer the following services:
- Regional Qualified Person for Pharmacovigilance (QPPV) services
- Local literature monitoring and screening
- Market-specific adverse event collection and processing
- Territory-specific regulatory reporting compliance
- Translation services for safety documentation
- Customised risk management strategies for regional markets
- Local signal detection and management services
- Local aggregate report preparation and submissions
- Local regulatory intelligence
We work closely with local authorities to stay current with evolving regulations, ensuring your pharmacovigilance activities remain compliant across all operational locations. Our services are also designed to smoothly integrate with your existing global frameworks. Through our interconnected processes, we help minimise redundancy and maximise efficiency in your safety operations.
Local intelligence to ensure global compliance with regulatory requirements.
Established Network
Access a network of fully trained and managed country experts (LPPVs and EU QPPVs) to support essential local PV activities.
Culture of Quality
Ensure an inspection-ready mindset to understand and meet both country-level and client expectations.
Reduce Effort and Costs
Streamline management and training of the local PV experts under an established, ISO accredited QMS platform.
Fully Managed Local PV Services
Global Reach
Global LPPV and EU QPPV coverage, including Europe, Middle East, Asia, and Latin America.
Inspection-Approved Processes
Processes to support end-to-end local pharmacovigilance activities in a compliant manner.
Technology-Enabled
Affordable, embedded technologies to support local literature management and translations activities.
Regulatory Intelligence
Cost-effective regulatory intelligence services to proactively plan and manage regulatory expectations.
Working with Qinecsa for Your Local PV Needs
By choosing Qinecsa, you gain access to local expertise so you can navigate regulatory complexities with confidence while focusing on your core business objectives. Our team of experienced professionals maintains regular communication with your organisation, providing transparent updates and responsive support. We prioritise building long-term relationships based on trust and excellence — serving as an extension of your pharmacovigilance team rather than being an external service provider.
