Your Trusted Partners for Quality Assurance and Regulatory Services…
WHY ARE WE HERE?
YOUR TRUSTED PARTNERS FOR GXP AUDITING SERVICES
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CRQA provide wide range of solutions for pharma and clinical research regulatory issues. Our team is well equipped to provide turnkey solutions for the regulatory issues in India for drugs and devices. Some of our key services are:
Global Pharmacovigilance audit
MAH audit
QPPV audit
Company affiliates audit
Business partner/Marketing partner audit
Vendor/Service provider audit (Literature search, Case processing Unit, Translations, Vendor (PSUR/PABER/RMP/ADCO, etc.)
Inspection/audit readiness
PV System Overview - Organisation Structure and responsibilities
Management and oversight of PV Operations globally.
Quality Management System - CAPA Management, KPIs and Metrics, Oversight of Quality Organisation,
Training Management – On boarding, Training, Mentoring, Documentation - JDs and CVs, Off boarding)
Business Continuity Planning
Information Security and Data Privacy
Pharmacovigilance System Master File
Individual Case Safety Reports - SOPs, Processes and Case reviews, Systems and Tools
Aggregate Reports - PSUR, PBRER, PADERs - SOPs, Processes and Reports review, Systems and Tools
Outsourcing, Vendor Oversight / Governance, Vendor Contracts
Contractual Documents
Governance Meetings
Oversight and communications between CRO-MAH: Compliance Dashboards/Metrices their Frequency/Periodicity
Management of Late Cases and USR
PADER Processes
Process to Manage HA requests and regulatory enquiries
Documents Archival process
Signal Management