SERVICES FOR THE PHARMACEUTICAL INDUSTRY
Audit Services
Services
PVpharm offers independent and comprehensive audit services to assess the quality and compliance of pharmacovigilance and clinical safety systems.
Our experts conduct GxP audits, vendor assessments, and risk-based evaluations, ensuring organizations are prepared for regulatory inspections. We provide clear, actionable recommendations to reinforce operational quality and align with international standards.
Should your organisation need an objective, professional audit, our team is available to assist you.
Planning and execution of internal and external audits
Effective audits require structured planning and expert execution. PVpharm supports the planning and conduct of internal and external audits across clinical safety and pharmacovigilance activities, ensuring objective assessments, regulatory alignment, and actionable outcomes.
GxP compliance audits (GVP, GMP, GDP, GLP)
GxP compliance audits are critical to meeting global regulatory expectations. PVpharm conducts comprehensive audits across GVP, GMP, GDP, and GLP domains, assessing compliance with applicable regulations and identifying areas for improvement to strengthen quality systems.
Vendor and third-party audits
Oversight of vendors and third parties is essential to maintain compliance across outsourced activities. PVpharm performs qualification and routine audits of vendors and partners involved in clinical safety and pharmacovigilance, supporting risk-based oversight and regulatory compliance.
Pharmacovigilance system audits
A robust pharmacovigilance system is central to patient safety. PVpharm conducts PV system audits to evaluate the effectiveness, compliance, and integration of safety processes, governance, and documentation against global regulatory requirements.
Audit reporting and CAPA follow-up
Clear reporting and effective CAPA management are key to audit success. PVpharm delivers structured audit reports and supports CAPA development, implementation, and follow-up, ensuring findings are addressed in a timely and compliant manner.
Inspection readiness and regulatory authority support
Regulatory inspections require ongoing preparedness and expert support. PVpharm assists organizations with inspection readiness activities and provides hands-on support during health authority inspections, including interaction management, documentation review, and response coordination.
