Pharmacovigilance organisations and systems

Pharmacovigilance organisations and systems

We have dedicated experienced consultants who are experts in the field of pharmacovigilance and are committed to provide any 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), procedures and Safety Data Exchange Agreements (SDEA)
  • Provision of EU or French QPPV services
  • In-house training on Pharmacovigilance
  • PV compliance

Blue Reg teams can support your in-country affiliates to develop PV systems and QMS.

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