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Doctor's Desk

Medical writing

  • Aggregate safety reports (PSUR, DSUR, signal detection reports)

  • Risk Management Plans

  • Clinical Overviews

  • Supporting documentation for safety variations and product information updates, responses to health authority safety related questions and requests

EU QPPV

  • Qualified Person for Pharmacovigilance

  • PSMF

  • QMS

  • Audit and inspection readiness 

  • Signal detection and management

  • Risk strategy and management 

Literature monitoring

  • Review of medical literature of global databases and local journals

  • For signal detection or ad hoc, for specific procedures or projects

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