Pharmacovigilance Compliance Practice

  1. PV Diagnostic Gap Assessments
  2. Inspection Readiness Remediations
  3. Functional Builds and Transformations
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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:

  1. 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
  2. Regulations, Guidance Documents, and Directives
  3. Understanding of current FDA (and ex-US) inspection focus areas
  4. Observed industry best practices, as well as standard practices
  5. Extensive business understanding based on multifarious therapeutic area experience and governance structure expertise

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