GVP Quality System
Development and implementation of a quality system compliant with GVP guidelines. Definition of organizational structure, responsibilities and processes to ensure full regulatory compliance.
GVP Compliant
Quality Assured
Our QA Services
Complete Quality Assurance Solutions
A specialized team for every aspect of quality management and regulatory compliance of your pharmacovigilance system.
SOP & Documentation
Drafting and review of Standard Operating Procedures, work instructions and document templates. Quality documentation lifecycle management according to industry best practices.
Internal & External Audits
Execution of system and product audits, both internal and towards suppliers and partners. Non-conformity identification and support in defining appropriate corrective actions.
Mock Inspection
Preparation and simulation of AIFA and EMA inspections to verify quality system readiness. Preventive identification of improvement areas before actual inspections.
CAPA Management
Structured non-conformity management through root cause analysis and definition of effective corrective and preventive actions (CAPA) with implementation monitoring.
KPI & Reporting
Quality trend monitoring and analysis through key performance indicators. Dashboards and periodic reports for corporate management and regulatory authorities.
Our Methodology
The Audit Process
A structured four-phase approach to ensure measurable results and lasting compliance.
1
01
Gap Analysis
Initial assessment of the quality system status against GVP regulatory requirements. Identification of non-compliance areas and intervention priorities.
2
02
Execution
Conducting the Audit or Mock Inspection according to a structured plan. Evidence collection, personnel interviews and system documentation verification.
3
03
CAPA Plan
Definition of preventive and corrective actions based on root cause analysis. Implementation plan with defined responsibilities and timelines.
4
04
Follow-up
Verification of corrective action implementation and their effectiveness. Formal closure of findings and document system update.
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Competence & Rigor
Quality by your side.
The most rigorous processes require the most expert minds. Our multidisciplinary team boasts decades of experience in conducting Audits and Mock Inspections, ensuring complete operational peace of mind and absolute compliance.
100%
REGULATORY COMPLIANCEScientific Precision
Our multidisciplinary team integrates physicians, pharmacists, regulatory experts and scientists with deep pharmacovigilance specialization, ensuring rigorous analysis and impeccable documentation.
1:1
GUARANTEED DIRECT ACCESSDirect Access to Decision-Makers
Our lean structure guarantees you direct access to project managers and an operational flexibility that large organizations cannot offer.
20+
YEARS OF EXPERIENCEZero Organizational Stress
We handle deadlines, GVP updates, EMA notifications and AIFA communications. You focus on your business: organizational management is in expert hands.
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