qointa
Qointa is a specialized provider of solutions and services for the regulated Life Sciences industry, including pharma, biotech, and medtech sectors. Their mission is to accelerate innovation, ensure compliance, and deliver impactful healthcare outcomes through digital transformation, regulatory assurance, data integrity, patient engagement, and software development. They focus on quality, regulatory mastery, and tailored solutions to meet the complex needs of their clients, ranging from startups to global industry leaders.
Industries
Nr. of Employees
small (1-50)
Products
Adherence platform for medication and therapy
Web- and mobile-accessible adherence solution that delivers reminders, collects real-time adherence and wellbeing data, and supports patient-brand engagement.
Remote patient monitoring platform
Platform that collects vital signs and patient-reported data (active and passive), packages and delivers data to clinicians and carers, and supports alerting and intervention workflows.
Patient registry and disease management platform
System to create disease-specific medical files and registries that bridge pretrial monitoring, clinical trial eCRFs and post-market real-world evidence collection.
Adherence platform for medication and therapy
Web- and mobile-accessible adherence solution that delivers reminders, collects real-time adherence and wellbeing data, and supports patient-brand engagement.
Remote patient monitoring platform
Platform that collects vital signs and patient-reported data (active and passive), packages and delivers data to clinicians and carers, and supports alerting and intervention workflows.
Patient registry and disease management platform
System to create disease-specific medical files and registries that bridge pretrial monitoring, clinical trial eCRFs and post-market real-world evidence collection.
Services
Quality and regulatory assurance consulting
Advisory and implementation services for QMS, regulatory strategy, technical file review and submission support for medical device and biotech clients.
EU Authorized Representative (EC REP) service
Acting as the official EU representative to fulfil MDR/IVDR obligations, manage technical files and liaise with EU authorities.
Computerized system validation & electronic data integrity services
Validation planning, audits, controls design and infrastructure qualification to meet 21 CFR Part 11 and Annex 11 requirements.
Digital transformation and Pharma 4.0 consulting
Roadmapping, technology selection and implementation support for digital modernization in manufacturing and clinical operations.
Regulatory-grade software validation and SaMD development
Design, development and validation of SaMD/SiMD including risk management, verification and documentation aligned with IEC 62304 and regulatory requirements.
Patient engagement, adherence and registry program implementation
Design and deployment of patient support programs, adherence reminder systems and disease-specific registries that integrate with clinical workflows.
Quality and regulatory assurance consulting
Advisory and implementation services for QMS, regulatory strategy, technical file review and submission support for medical device and biotech clients.
EU Authorized Representative (EC REP) service
Acting as the official EU representative to fulfil MDR/IVDR obligations, manage technical files and liaise with EU authorities.
Computerized system validation & electronic data integrity services
Validation planning, audits, controls design and infrastructure qualification to meet 21 CFR Part 11 and Annex 11 requirements.
Digital transformation and Pharma 4.0 consulting
Roadmapping, technology selection and implementation support for digital modernization in manufacturing and clinical operations.
Regulatory-grade software validation and SaMD development
Design, development and validation of SaMD/SiMD including risk management, verification and documentation aligned with IEC 62304 and regulatory requirements.
Patient engagement, adherence and registry program implementation
Design and deployment of patient support programs, adherence reminder systems and disease-specific registries that integrate with clinical workflows.
Expertise Areas
- Clinical trial management and eClinical systems
- Regulatory compliance and medical device registration
- Quality Management Systems (QMS) for life sciences
- Software development and validation for regulated products
Key Technologies
- Cloud-based analytics and hosting
- Electronic data capture (eCRF)
- ePRO / eCOA systems
- Remote patient monitoring platforms