Our expert compliance and Pharmaceutical Mock Audits ensure your pharmaceutical operations meet all regulatory requirements. We identify gaps, implement corrective actions, and establish robust quality systems to maintain continuous compliance and prepare for successful regulatory inspections.
Comprehensive audits of manufacturing and distribution facilities to ensure compliance with GMP/GDP. We offer specialized staff GMP training to address findings.
Design, development, and implementation of comprehensive Quality Management Systems (QMS) aligned with international standards and regulatory requirements.
Simulated regulatory audits to prepare your team for official inspections, identifying potential issues before they become compliance risks.
Thorough review of quality documents, SOPs, batch records, and validation protocols to identify gaps and ensure regulatory compliance.
Systematic investigation to identify underlying causes of compliance issues and quality deviations
Immediate actions to eliminate identified non-conformities and prevent recurrence
Proactive measures to prevent potential non-conformities before they occur
Continuous monitoring and verification of CAPA implementation effectiveness
Document review and preliminary gap analysis
Comprehensive facility inspection and process evaluation
Detailed findings, risk assessment, and priority recommendations
Assistance with CAPA implementation and system improvements
Verification of corrective actions and continuous improvement monitoring
A Gap Analysis is a detailed review of your current systems against regulatory standards to identify missing elements. A Mock Audit simulates an actual inspection scenario (like FDA or SFDA) to test your team's readiness and immediate response capabilities.
Yes, we don't just identify the gaps; we support you in investigating root causes, defining Corrective and Preventive Actions (CAPA), and verifying their effectiveness to ensure sustainable compliance.
Yes, we specialize in preparing facilities for MENA region authorities like SFDA. We conduct pre-inspection audits, review your site master file, and train your staff on how to handle the inspection process.
The duration depends on the facility size and scope of the audit. Typically, an on-site audit takes 2-4 days, followed by report generation and a close-out meeting.
Yes, Data Integrity is a critical part of our audits. We review your electronic and paper-based systems to ensure data accuracy, completeness, and consistency (ALCOA+ principles).
Contact our compliance experts today for comprehensive gap analysis and audit services to prepare your facility for regulatory inspections.