Organisations & Systems

Organisations & Systems

Bluereg has dedicated experienced consultants who are experts in the field of pharmacovigilance.
We are committed to provide assistance you may need in any of your Pharmacovigilance and Risk
Management activities. We can assist you in the following:


  • Advice on the organisation of your PV department
  • Setting up your pharmacovigilance system
  • Preparation of your Pharmacovigilance System Master File (PSMF), and Safety Data Exchange Agreements (SDEA)
  • In-house training on Pharmacovigilance
  • Setting-up quality management system (management review, quality review, writing SOP, setting up quality indicators…)

“All these missions are carried out according to the requirements and modalities of Good Vigilance Practices and local


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