Quality & compliance

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

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

CAPA Management

Established CAPA management process in line with client pharmacovigilance conventions.

Audit support

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

Pharmacovigilance Training

Integrated, compliant training framework including development of Standard Operating Procedures & Work Instructions in accordance with pharmacovigilance quality requirements.

Quality & Compliance

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
Japan, EU, US, UK, Canada, India, UAE

Experience of conducting audits