Your specialist partner for technology-enabled drug safety

Qinecsa are redefining drug safety with our technology-enabled, full lifecycle pharmacovigilance solutions, 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.

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.

Innovation Spotlight

We have created industry-leading, end-to-end solutions for capturing, managing, and evaluating drug safety data more efficiently and accurately.

Technology-Enabled Services

Rising safety data volumes, regulatory pressure and fragmented operating models are increasing complexity across pharmacovigilance. Qinecsa’s Technology-Enabled Services deliver the benefits of advanced PV technology, automation and AI through a fully managed service model, helping organizations modernize faster, improve efficiency, reduce vendor complexity and strengthen compliance without investing in or managing additional technology platforms internally.

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.

Advancing Drug Safety Solutions to the Next Level

We partner with life science companies to strengthen safety, drive progress and help protect patients worldwide.