Our Difference

Our Skill Set

When other consulting organizations propose Pharmacovigilance Audits, you should ask: "Why choose PV Focus?"

There are two types of service providers offering Pharmacovigilance Audits:

• Clinical Quality Assurance Service Providers:
  This includes free-lance auditors and other CQA consulting companies. These offer a wide range of activities related to Clinical Quality Assurance, which includes clinical investigators site audits, system audits, document audits, SOP writing and training. Those are generally trained Auditors, but may not offer the necessary Pharmacovigilance expertise your business requires.
  


• Contract Safety Surveillance Organizations:
  This type of service provider offer consulting and support to the day-to-day operations of a Pharmacovigilance department, e.g. PSUR writing, MedDRA support, etc… Those bring their expertise of Pharmacovigilance, but they may not possess the auditing mindset necessary to critically evaluate your processes.

PV Focus is at the crossroads between Auditing and Pharmacovigilance, with more than 10 years experience covering all types of Auditing activities and over 3 years of active involvement in Pharmacovigilance. This experience was gained throughout Europe, the Americas and Asia. Moreover, PV Focus possesses first hand experience of Pharmacovigilance Inspections, which guarantees that the expectations of the leading Regulatory Authorities in this field are fully reflected in the audit process.

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Our Edge

This extensive experience of Pharmacovigilance Auditing is reflected in the high-quality services we offer. In particular, our PV Audit Set entails a pre-defined Audit Plan covering all expectations of the leading Regulatory Inspectorates in the world, to guarantee the most cost-effective and comprehensive approach to Pharmacovigilance Auditing of any relevant organization.

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