We offer full range Pharmacovigilance Services for Investigational Medicinal Products (IMPs) and Medical Devices during
clinical trials
and Authorised Medicinal Product after Marketing Authorisation:
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Implementing a pharmacovigilance system according to the legislation
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Writing of your SOPs
- PSMF maintenance
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Support during Audits and Inspections
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Training of your PV personnel or all company employees
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outsourcing
of pharmacovigilance personnel
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24/7 Safety Physician Service
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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
- Medical Information Contact Center services in the Nordic Countries
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Translation of pharmacovigilance and regulatory documents in Finnish as well as the Scandinavian languages
Safety Database:
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Meeting all regulatory requirements
- Full processing of Adverse Reaction Reports during clinical trials and post-marketing, including Medical Assessment by our Safety Physician
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MedDRA coding (personnel trained in MedDRA)
Risk-benefit/Signal Detection:
- Signal Management
- Browsing both global and local literature
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Risk Management Plan
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Periodic Safety Update Reports (PSURs)
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Development Safety Update Reports (DSURs)
- Routine monitoring of new legislation
EudraVigilance:
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EudraVigilance registration of MAH/Sponsor/Users
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Expedited reporting of ICSRs and SUSARs to EudraVigilance
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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.