Ensuring Robust and Compliant Safety Systems
At BioVigilant Pharmacovigilance, we recognize the critical role that audits play in maintaining compliance and ensuring the integrity of pharmacovigilance systems. Our pharmacovigilance audit services provide an independent and thorough evaluation of your processes to ensure adherence to global regulatory requirements and industry best practices.
Comprehensive Audit Expertise
We offer end-to-end auditing solutions designed to strengthen your safety management system and identify areas for improvement, empowering you to maintain the highest standards in drug safety.
Our Services Include
Systematic Gap Analysis
Identifying vulnerabilities in your pharmacovigilance system and offering actionable recommendations for optimization.
Regulatory Compliance Audits
Ensuring compliance with regional and global pharmacovigilance guidelines, including FDA, EMA, and ICH standards.
Mock Inspections
Simulating regulatory inspections to prepare your team and processes for official evaluations.
Corrective and Preventive Action (CAPA) Planning
Developing detailed CAPA plans to address audit findings effectively and ensure ongoing compliance.
Audit Reporting and Follow-Up
Delivering comprehensive reports and support to implement recommendations seamlessly.
Why Choose
BioVigilant?
BioVigilant’s pharmacovigilance audits are designed to enhance the reliability of your safety management systems, ensuring confidence in regulatory inspections and patient safety.
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