As one of the leading providers of Pharmaceutical Regulatory Affairs & Pharmacovigilance services, one of the areas we have developed deep experience in is auditing, both as the auditee and the auditor (as part of our Vendor Management System).
Our Auditing Experience
We are audited numerous times each year as part of the audit trail from our clients as they themselves either prepare to be audited or, as part of a health agency inspection, where we are part of the system they maintain. Moreover, we are inspected by Health Agencies for our Pharmacovigiulance system. This gives us a unique angle to understand what is required in order to be compliant. As part of our ISO9001 Quality Management System, continual improvement is integral to our thinking, so when we get audited, we learn from it and make improvements, no matter how small they may be.
AIR™ - Audit and Inspection Readiness
Our offer is that we can provide auditing services across a number of different areas. We can provide different levels of audit support based on your requiremements and all audits are tailored to your understanding and needs. These are as follows:
Quality Management System
Clinical Supplier Audits