GVP
Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. Our team of GVP auditors is experienced and dedicated to providing required PV QA oversight. We ensure that audits performed are not done so in isolation and include additional critical information that we provide to our client’s in-house QA teams. Risk assessments and impact of such risk as well as exposure to risk elements to the processes that will affect an organisation is highlighted.
Pharmacovigilance Audits
- PV Systems Audits
- PSP Audits
- PV Vendor Selection Audits
- PV Project Specific Audits at Vendors
- PV Database Audit (Including CSV Components)
- PSMF Audits
- CT PV Process Audit (CRO)
- Other strategic projects within PV
In addition, to the audits we also have worked with QA organisations to accomplish some important Quality Projects, these strategic projects highlight on various aspects including Risk Based Auditing program development, Comparison and evaluation of PV services for 3 vendors before finalising the vendor.
