Quality Assurance & Audits
Quality Assurance & Audits
The need for audit is well-established in GCP and many regulations. The importance of audit, especially of partners, cannot be over-emphasised.
It is very challenging, for example, for a QPPV that is based in a Belgian office to keep the required oversight of the company’s marketing partner in Bahrain effectively. It is challenging to ensure that the Bahraini partner has the pharmacovigilance system in place and is maintaining the required compliance with local regulations and the inter-company pharmacovigilance agreement.
This is where we come in. We can audit your partner and provide your organisation with a full report and recommendations. We can work together to effect some of the recommended CAPAs and even take over some of the roles of your partners, if required, to help organisation maintain full compliance.