Pharmacovigilance Compliance Practice
- PV Diagnostic Gap Assessments
- Inspection Readiness Remediations
- Functional Builds and Transformations
We have accumulated countless hours working with worldwide regulatory inspectors in pre and post-marketing environments and with the Drug Safety aspects of BIMO inspections.
After a diagnostic gap assessment of your PV function, we will provide a remediation roadmap guided by five critical elements:
After a diagnostic gap assessment of your PV function, we will provide a remediation roadmap guided by five critical elements:
- Our "Deep Dive" gap assessment results will yield predictive inspection topics and approximate lines of questioning and investigation that will be targeted at your organization
- Regulations, Guidance Documents, and Directives
- Understanding of current FDA (and ex-US) inspection focus areas
- Observed industry best practices, as well as standard practices
- Extensive business understanding based on multifarious therapeutic area experience and governance structure expertise