We can support you with:

  • Pharmacovigilance outsourcing
  • Act as your Local safety officer
  • Monitoring local scientific literature
  • Pharmacovigilance audits
  • Post Inspection projects
  • Create and update of SOP’s, Work Instructions, or templates
  • Assessment of existing Pharmacovigilance System and analysis of gaps
  • Pharmacovigilance training
  • Safety Data Exchange Agreements (SDEA’s)
  • Medical information, monitoring of in-boxes, back-up
  • Translation of pharmacovigilance documents and reports in Swedish, Danish, Norwegian and Finnish

We can also provide other services, please contact us for a discussion on how we can help you.


Helena Björkman
Head of Regulatory Affairs Sweden and Nordics
+46 (0)70-165 22 77

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