Pharmacovigilance Audit Services

Our Pharmacovigilance Audit offers comprehensive evaluations of pharmacovigilance systems including its QMS, processes, and practices to ensure compliance with regulatory requirements and GVP.

Our experienced auditors conduct thorough assessments of pharmacovigilance activities, providing actionable insights and recommendations to enhance compliance and adherence to industry best practices.

1. Systematic Evaluation: Our audits cover all aspects of pharmacovigilance, including case processing, signal detection, risk management, quality management, and regulatory compliance. We assess the effectiveness, efficiency, and robustness of your pharmacovigilance systems and processes to identify areas for improvement and optimization.
2. Regulatory Compliance: Our audits are conducted in accordance with applicable regulatory requirements and guidelines, including those set forth by regulatory authorities such as the EDA, SDFA, FDA, EMA, and ICH. We ensure that your pharmacovigilance activities adhere to current regulations and standards, minimizing the risk of regulatory non-compliance.
3. Risk Identification: We identify potential risks and deficiencies in your pharmacovigilance systems and processes that may impact patient safety or regulatory compliance. Our audits provide valuable insights into areas of vulnerability and opportunities for risk mitigation and improvement.
4. Actionable Recommendations: Following the audit, we provide detailed audit reports outlining our findings, observations, and recommendations for corrective and preventive actions. Our recommendations are practical, actionable, and tailored to address identified deficiencies and enhance the effectiveness of your pharmacovigilance operations.
5. Follow-Up Support: We offer ongoing support and guidance to help you implement the recommended actions and address any outstanding issues identified during the audit. Our team is available to provide assistance and expertise throughout the remediation process, ensuring that your pharmacovigilance systems and processes are strengthened and optimized.

1. PV Full System Audit.
2. PV Risk-Based Audit.
3. Affiliate Audit.
4. CMO/distributor audit.
5. Qualification of PV Vendor Audit.
6. PV Pre-inspection Support.

 Ensure the integrity and compliance of your pharmacovigilance operations with our Pharmacovigilance Audit Services. 

Contact us today to schedule an audit and take proactive steps toward optimizing your pharmacovigilance processes.