PHARMACOVIGILANCE
Establishment and maintenance of pharmacovigilance systems.
  • Maintaining the pharmacovigilance system of your products throughout the entire lifecycle.


  • Case Management: the processing of product safety information on your behalf, including:
  • Maintaining the product safety register.
  • Processing and reporting electronically.
  • Providing medical evaluation and signalling (risk-benefit evaluation).
  • Archiving documents appropriately.
  • Narrative writing.
  • Literature surveillance and review: literature published internationally (Medline), locally and documentation / processing Medical Literature Screening results in case of your product safety information.

  • Regulatory Intelligence – keep up to date with regulatory guidelines and amendments to legislation.
  • Contact towards authorities on your behalf.
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