Our expert compliance and gap analysis services 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 Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) regulations.
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
Contact our compliance experts today for comprehensive gap analysis and audit services to prepare your facility for regulatory inspections.