Ensuring global regulatory readiness through rigorous gap analysis, quality system optimization, and realistic mock inspection simulations.
Lumicure Pharm provides expert compliance assessments and pharmaceutical mock audits to ensure your operations meet international regulatory standards. We identify critical gaps, implement robust Corrective and Preventive Actions (CAPA), and optimize Quality Management Systems (QMS) for sustained compliance.
Our auditors bring extensive experience from health authority inspections (FDA, EMA, SFDA), providing you with a realistic assessment of your site's readiness and a clear roadmap for remediation.
Comprehensive facility inspections and process evaluations to verify strict adherence to current Good Manufacturing/Distribution Practices.
Realistic simulations of official health authority inspections to evaluate staff performance and system robustness under stress.
Modernizing QMS documentation, protocols, and data integrity frameworks to align with evolving global regulatory expectations.
Comprehensive off-site review of Site Master Files, quality manuals, and critical system documentation.
Thorough field evaluation of manufacturing facilities, equipment validation, and operational workflows.
Categorized findings report (Critical, Major, Minor) with detailed impact assessments on compliance status.
Strategic support for implementing sustainable corrective and preventive actions with long-term monitoring.