EudraVigilance Services

AXPHARMA has anticipated the regulatory changes related to EudraVigilance and can offer you its services now. Contact us to help you comply with this new regulation.


AXPHARMA EudraVigilance Services includes, but are not limited to:

  • Change management & communication plan
  • Registration with EudraVigilance for pharmaceutical companies
  • Provision of Responsible Person (& ‘Trusted’ Deputy)
  • Arrangement of QPPV EV services
  • Registration of individual users (‘HQ’/Third party service provider/Affiliate level)
  • Registration & testing with National Competent Authorities
  • EV training plan & kits (PPT, Video, Quiz)
  • Case management of suspected adverse reactions, including contact with reporters, MedDRA coding, Data Entry and Electronic reporting to EMA via EVWEB
  • Introduction of information of medicinal products in XEVMPD
  • Medical Literature searches for Pharmacovigilance including MLM services
  • Signal detection via EVDAS tool starting on November 22nd, 2017
  • Review of internal registration documentation
  • Maintenance of EV registrations (staff movements, changes in legislation etc.)
  • Review of EudraVigilance-related pharmacovigilance documentation
  • EV testing and legacy data transfer (E2B standards)
  • End user Training pharmacovigilance and GVP


  • Vigilance Systems Services

AXPHARMA Vigilance Systems Services includes, but are not limited to:

  • Project Management
  • Safety database consultancy
  • E2B (R3) system implementation
  • Database validation tasks (Validation Master Plan, Risk Analysis, Test Plan, Protocols, Validation Summary Report)
  • Legacy data migration (consulting services and validation)
  • Database administration and maintenance