GVP Audits
At PHARMEXPERT CONSULTANT LLP, our Good Pharmacovigilance Practice (GVP) Audits ensure that pharmaceutical companies maintain full compliance with global pharmacovigilance regulations and industry standards. These audits are vital for promoting the safe and effective use of pharmaceutical products by ensuring that all safety monitoring systems function efficiently and consistently.
Our skilled and experienced quality auditors — specialized in pharmacovigilance (PV) and clinical operations — provide comprehensive assessments that help companies remain inspection-ready and aligned with international regulatory expectations.
Mandatory Audits for Regulatory Compliance
We conduct GVP audits to assess and strengthen compliance frameworks within organizations, ensuring that pharmacovigilance systems operate effectively, risks are minimized, and reporting obligations are met with accuracy and transparency.
Company Affiliates
Includes audits of country offices, local operating companies, and marketing subsidiaries.
Licensing & Business Partners
Evaluates pharmacovigilance responsibilities and data-sharing agreements with partners and distributors.
Pharmacovigilance Process Audits
Reviews the effectiveness of individual PV processes such as case management, signal detection, and reporting.
Pharmacovigilance System Audits
Provides a holistic assessment of the organization’s PV framework to ensure robust governance and regulatory compliance.
Identify audit scope, roles, and responsibilities; review all relevant documentation.
Align with stakeholders and set clear expectations for the audit process.
Perform detailed assessments through document reviews, interviews, and process evaluations.
Present findings and discuss observations with key stakeholders.
Deliver a comprehensive report highlighting gaps, risks, and actionable recommendations for improvement.