Quality Audits
Quality Audits
Our objective is to identify potential non-conformances, assess the maturity of the quality system, and prepare the company for official inspections, thereby minimizing risks and enhancing the likelihood of success.
Regulatory Mock Audits and Action Plan
T&B Pharma Consulting teste conducts pre-audit inspectors focusing on regulatory compliance assessment of the main national and international inspection bodies, including:
- Anvisa (Brazil)
- MAPA
- FDA (USA)
- EMA (Europe)
- WHO (World Health Organization)
Services
- Conducting MOCK audit with technical and careful approach, simulating real regulatory inspections.
- A detailed technical report on the evidence presented, highlighting any deviations from standards, and suggesting areas for improvement.
- Collaborate with your team on the Action Plan-CAPA, utilizing route cause analysis and criticality assessment.
- Monitoring and follow-up of the implementation of corrective and preventive actions, ensuring their effectiveness and traceability.
Let’s get everything ready ahead of time!
With years of experience in both national and international inspections, our team is ready to lend a hand to your business throughout the inspection, action plan, and CAPA process.
