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
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.
Audit support
Strategies to support a risk-based approach to client audit requirements. Complete range of GxP audits undertaken across geographies with recommended CAPAs & audit certificate.
Pharmacovigilance training
Integrated, compliant training framework including development of Standard Operating Procedures & Work Instructions in accordance with pharmacovigilance quality requirements.