The three steps to compliance:
OUR TECHNOLOGY SYSTEM: DATABASE

Compliant Safety Systems

QVigilance can set up and host your global safety database on our 21 CFR Part 11 / Eudralex Annex 11 and native E2B(R3) validated AB Cube SafetyEasy system which is compliant with the latest reporting requirements. We also provide our iQ customer portal where documents can be easily accessed and managed.

Clients Testimonials

"The team has always provided a very positive experience and professional service."
Bruno Maranda, MD, M.Sc.
President and Medical Director at MendeliKABS
"Quanticate has provided PV services for us for nearly a year now.  I have found them incredibly professional and supportive.  They have deep expertise which they match with a strong customer focus and responsiveness that make them ideal partners"
Chief Operation Officer

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New PV practice guidance on ...

28 Apr, 2022

European Medicines Agency releases new draft good pharmacovigilance practice guidance on pregnancy prevention programmes and other pregnancy-specific risk minimisation measures. The European Medicines Agency (EMA) has ...

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Updated guidance on QPPV and PSMF ...

10 Sep, 2020

The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020, since then, there has been a transitionary arrangement in place maintaining the status quo regarding EU regulations on goods and services ...

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UK Government publishes updated ...

10 Sep, 2020

The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and since that time has been in a transition ‘phase’, during which time the UK and EU have been operating under EU regulations ‘acquis ...

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