Advancing Drug Safety with Innovative Digital Pharmacovigilance Solutions
Qinecsa are redefining drug safety with our technology-enabled, full lifecycle pharmacovigilance services, designed to help pharmaceutical companies stay ahead in an evolving regulatory landscape.
Our Industry-Leading Drug Safety Technology Platforms
Best-in-class technology that integrate with the pharmacovigilance landscape to reshape business processes.
Reportum
Market Leading Intake - a unified, direct from source SaaS technology to standardise and streamline the initial capture and follow up of adverse events, medical information, and product quality data.
HaloPV
Best in Breed Safety Platform – a modular pharmacovigilance platform that integrates with, rather than replaces, existing ecosystems. Deploy as a full lifecycle solution or leverage targeted capabilities within your PV processes.
Vigilance Workbench (QVW)
The Gold Standard for Signal Detection and Management – a single, feature rich, integrated platform, built by the pioneers in advanced safety signalling and trusted by top 10 global pharma.
Our Comprehensive Pharmacovigilance Services
Supported by the highest caliber of medical and scientific staff to generate rapidly vital safety insights.
Case Management
Provides ICSR management, literature screening and review, data migration, medical review of ICSRs, and submissions.
Signal & Risk Management
Supports signal detection and management, benefit risk management (RMP, REMS), drug safety physician services, and regulatory responses.
Quality and Compliance
Delivers PV audit-as-a-service, QPPV services, Eudravigilance setup and maintenance, and PSMF setup and maintenance.
Clinical Safety Management
Manages SAE and SUSAR workflows, delivers drug safety and reporting training, and supports safety management plan development.
Medical Writing
Produces aggregate reports, supports protocol review, and delivers risk management reports.
Pharmacovigilance Consulting
Offers PV management consulting, PV benchmarking, regulatory intelligence, and pharmacovigilance training.
Healthcare Analytics
Advances the science of signal detection, supports public health and regulatory agencies, and delivers complex customized analyses.
Medical Information Call Center
Provides a 24/7 multilingual call center for intake and follow up, including the design and maintenance of FAQs.
All Services
In this era of rapid evolution, Qinecsa’s unrivalled pharmacovigilance service offerings empower companies to adapt, ensure patient safety, and successfully support their invaluable product portfolios.
Who Are Qinecsa
We are trusted, global partners bringing together best-in-class technology and scientific expertise to connect life science companies, public health, and regulatory sectors to the right safety solutions.
From end-to-end pharmacovigilance and clinical safety support to signal and risk management, medical information, and advanced analytics, we help organizations build safer, more resilient operating models that perform under real-world pressure.
- Global safety specialists supporting pharma, biotech, med device, and public health organizations
- Technology-enabled services that improve consistency, control, and efficiency
- Deep scientific expertise across case, signal, risk, quality, and compliance workflows
- Practical, partnership-led support designed to scale with your needs
Trusted support, built for real-world drug safety
At Qinecsa, we combine scientific expertise and technology to support the way safety functions operate in practice, not just on paper.
We partner with your team to strengthen oversight, improve consistency, and help you stay inspection-ready as your portfolio, partners, and reporting demands evolve. Whether you need operational support, strategic guidance, or specialist insight, we help you move forward with greater control and confidence.
Talk to a PV Specialist
Innovation Spotlight
We have created industry-leading, end-to-end solutions for capturing, managing, and evaluating drug safety data more efficiently and accurately.
Quantitative Signal Detection as a Service
Transform your pharmacovigilance data into clear, reliable and actionable safety insights. Qinecsa combines proven statistical methodologies, global pharmacovigilance expertise, and transparent, auditable processes to deliver reliable signal detection you can trust. With access to high-quality data, validated analytics, and direct expert support, organisations gain clear, actionable insights without the cost and complexity of building internal capabilities.
Medical Device Vigilance
Qinecsa is the provider of choice for Medical Device Vigilance, combining deep regulatory expertise, proven post-market surveillance capability and a single, feature rich, integrated signal detection and management platform to protect patients and reduce compliance risk. We help organisations meet complex EU, US and global device vigilance requirements while maintaining clear oversight, operational efficiency and inspection readiness across every market.
Working with Reportum’s digital-first capabilities from the very start of our first product launch has ensured that we receive high quality adverse event and product quality data more efficiently—direct from sources such as consumers, healthcare professionals, and employees. The platform has enabled us to streamline our case intake process while delivering a strong ROI.
Additionally, Reportum’s scalability makes onboarding new partners, such as specialty pharmacies, seamless, keeping us agile and prepared for future portfolio and case volume
growth.
Christy Rathjens, MBA, RPhT
Sr. Director, Global Patient Safety, Aurinia Pharmaceuticals Inc.
Since partnering with Qinecsa in 2009, our joint team collaboration has steadily evolved into a strong and reliable working relationship. Their flexibility, proactive approach, and openness in discussions have been key to a smooth and dependable collaboration.
Head of Global Patient Safety
Gedeon Richter
Advancing Drug Safety Solutions to the Next Level
We partner with life science companies to strengthen safety, drive progress and help protect patients worldwide.