Gap analysis and mock audits to identify and address compliance risks before regulatory inspections.
Thorough review of SOPs, PSMF, and safety data to ensure all documentation meets GVP requirements.
Staff training and simulation exercises to prepare your team for real-world regulatory inspections.
Support in developing and implementing Corrective and Preventive Actions (CAPA) post-audit or inspection.
Expert guidance and communication with regulatory authorities during audits and inspections.
Ongoing support to maintain GVP compliance and audit readiness throughout your PV operations.
Assistance with regulatory responses and implementation of inspection findings.
Customized audit and inspection preparedness plans to fit your organization’s unique needs.