Expert support to ensure a compliant and audit-ready pharmacovigilance system.
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
Certified auditors, equipped with quality management systems to help plan, execute, and close inspections in line with Regulatory requirements, guidelines, and standards.
Established CAPA management process in line with client pharmacovigilance conventions.
Strategies to support a risk-based approach to client audit requirements. Complete range of GxP audits undertaken across geographies with recommended CAPAs & audit certificate.
Integrated, compliant training framework including development of Standard Operating Procedures & Work Instructions in accordance with pharmacovigilance quality requirements.
Experience in PV audits & inspections
ISO 9001 & 27001
Experience in standards
Japan, EU, US, UK, Canada, India, UAE
Experience of conducting audits