Phlox PVMed Consultancy has the expertise to provide external and independent review of the end to end Benefit Risk and Pharmacovigilance process within a company. We offer bespoke solutions such as
- a gap analysis for companies opening their first site in a new regulatory region, such as a US company opening their first UK or EU site
- SOP and process routine review to check for changes to global and local regulations since the documents were originally published
- re-training and re-certification of staff following a CAPA finding in an audit
- inspection readiness preparation