Pharmacovigilance services

We offer full range Pharmacovigilance Services for Investigational Medicinal Products (IMPs) and Medical Devices during clinical trials and Authorised Medicinal Product after Marketing Authorisation:

  • Implementing a pharmacovigilance system according to the legislation
  • Writing of your SOPs
  • PSMF maintenance
  • Support during Audits and Inspections
  • Training of your PV personnel or all company employees
  • outsourcing of pharmacovigilance personnel
  • 24/7 Safety Physician Service
  • Medical review of ICSRs, PSURs, DSURs, RMPs
  • 24/7 availability of Qualified Person Responsible for Pharmacovigilance in the EU (QPPV)
  • 24/7 availabiltiy of Deputy QPPV in the absence of the QPPV
  • Translation of pharmacovigilance and regulatory documents in Finnish as well as the Scandinavian languages

Safety Database:

  • Meeting all regulatory requirements
  • Full processing of Adverse Reaction Reports during clinical trials and post-marketing, including Medical Assessment by our Safety Physician
  • MedDRA coding (personnel trained in MedDRA)

Risk-benefit/Signal Detection:

  • Signal Management
  • Browsing both global and local literature
  • Risk Management Plan
  • Periodic Safety Update Reports (PSURs)
  • Development Safety Update Reports (DSURs)
  • Routine monitoring of new legislation

EudraVigilance:

  • EudraVigilance registration of MAH/Sponsor/Users
  • Expedited reporting of ICSRs and SUSARs to EudraVigilance
  • Registration in eXtended EudraVigilance Medicinal Product Dictionary, XEVMPD
  • Weekly collection of ICSR from EVWEB according to the EudraVigilance Aceess Policy L2A, or from the EMA medical Literature Monitoring Service

We customize a cost effective pharmacovigilance solution after our first meeting and initial analysis. Do not hesitate to contact us if you have any questions you need to discuss.