Quality & Compliance
Qinecsa provide quality and compliance services to support clients in audit and inspection readiness, SOP writing, data privacy adherence, pharmacovigilance training, PSMF maintenance and CAPA management.
Expert support to ensure a compliant and audit-ready pharmacovigilance system.
Audit Readiness
Deep-rooted pharmacovigilance expertise to understand regulation, system implementation, and monitoring and ensure ongoing effectiveness.
Keep Your Project ‘Green’
Robust quality management system to ensure processes are compliant with global and local Regulatory requirements.
Manage the Regulatory Landscape
Knowledgeable Quality & Compliance team that proactively supports clients to adapt as Regulatory requirements evolve.
Quality & Compliance Expertise
Eudravigilance Setup & Maintenance
- Dedicated team for EudraVigilance systems management.
- EVWEB support for SUSARs and ICSRs.
- XEVMPD support for SmPC and authorization updates.
- EVDAS support for eRMRs and case reports.
PSMF Setup & Maintenance
- Maintain PSMF integrity with comprehensive documentation.
- Continuous oversight ensures audit-ready PSMF.
- Immediate PSMF access for authorities.
- Active change control for PSMF management.
PV Audit-as-a-Service
- Comprehensive audit services for compliance.
- System audits cover scheduling and support.
- Gap analysis identifies compliance improvements.
- Inspection preparedness with readiness plans.
QPPV Services
- Expert pharmacovigilance leadership.
- EU and UK QPPVs with EudraVigilance registration.
- Local EU pharmacovigilance support.
- Backup arrangements with expert medical access.
Inspection Readiness
Certified auditors, equipped with quality management systems to help plan, execute and close inspections in line with regulatory requirements, guidelines and standards.
CAPA Management
Established CAPA management process in line with client pharmacovigilance conventions.
Quality & Compliance Credentials
Our diverse range of clients benefit from an operating model strengthened by a pharmacovigilance quality system that meets the evolving global Regulatory obligations while protecting our clients and their systems.
12 Years
Experience in PV audits & inspections
ISO 9001 & 27001
Experience in standards
UK, EU, US, Canada, India, UAE, Japan
Experience of conducting audits
Advancing Drug Safety Solutions to the Next Level
We’re working with life science companies to drive progress and continue protecting lives.