An independent external perspective can provide valuable assurance and insight into the effectiveness of your pharmacovigilance system. At ComplyX Consulting Ltd, our auditors bring extensive experience supporting and leading organisations through major regulatory inspections and compliance programmes.

We conduct a broad range of pharmacovigilance audits and assessment activities, including full PV system audits, process-specific audits, partner and vendor audits (including PSP providers), and inspection readiness assessments. Our approach is designed to identify compliance gaps, strengthen operational effectiveness, and support continuous improvement across your PV quality system.

This includes the submission and maintenance of key pharmacovigilance (PV) system information with the Medicines and Healthcare products Regulatory Agency (MHRA), including:

• UK Qualified Person for Pharmacovigilance (UK QPPV)/National Contact Person details

• Pharmacovigilance System Master File (PSMF) location

• Pharmacovigilance contact and safety reporting information

These regulatory details must be submitted before a medicinal product is placed on the UK market and kept accurate and current throughout the product lifecycle to ensure ongoing compliance with UK pharmacovigilance requirements.

Inspection readiness audits specific to key global territories, including the EU and the US, have been conducted as part of the pharmacovigilance quality management system to support continuous inspection preparedness.

These audits have been performed in accordance with applicable pharmacovigilance regulatory requirements, including UK GVP and the Human Medicines Regulations 2012 (as amended) for the United Kingdom; 21 CFR Parts 312 and 314, together with FDA pharmacovigilance requirements, for the United States; and the Food and Drugs Act, Food and Drug Regulations, and Health Canada Pharmacovigilance Guidelines for Canada.

Compliance in pharmacovigilance (PV) is essential to ensure the ongoing safety of medicinal products and to meet regulatory requirements. A robust PV system enables Marketing Authorisation Holders (MAHs) to effectively monitor product safety, identify and assess risks, and implement appropriate risk minimisation measures while maintaining regulatory confidence and inspection readiness.

To support PV compliance, organisations may benefit from services including PV system and vendor audits, inspection readiness assessments, compliance reviews, gap analyses, procedure development, staff training, and support with maintaining key system elements such as the Pharmacovigilance System Master File (PSMF). These activities help strengthen operational effectiveness and ensure continued alignment with regulatory expectations.

• End-to-end GxPV quality systems that deliver compliance, confidence, and inspection readiness.

• Practical GxPV quality frameworks that meet regulatory expectations and work in real operations.

• Quality-led pharmacovigilance designed to protect patients, approvals, and business continuity.

We support the design and implementation of effective pharmacovigilance (PV) governance frameworks aligned with global regulatory requirements and organisational objectives, including:

• Development of PV governance and oversight structures

• Establishment of safety committees, governance forums, and decision-making processes

• Definition of clear accountability models, including QPPV support and delegation oversight

• Design of metrics, KPIs, and reporting frameworks to provide meaningful visibility of PV performance, compliance, and risk management