Remain compliant and safeguard your patients

As a Pharmacovigilance Service Provider focused on Biopharmaceuticals we will meet all your clinical trial and post-authorisation needs

 

 

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The three steps to compliance:

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  • Secure a meeting with our experts
  • Put in place a CDA/NDA
  • Specify your needs and requests 
  • Our specialist will guide you to a tailored outsourcing solution
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Part of your team >

  • Kick-off meeting and selection of the preferred approach
  • QVigilance resources assigned to your team to meet your regulatory needs
  • Excellent customer care

 

 

 

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Compliance Achieved!

  • All your regulatory and business requirements are meet
  • Your PV system is in perfect compliance with EMA and FDA's regulations
  • You acquired a trusted partner, and we stay at your disposal for any future needs

OUR SERVICE OFFER

Global Pharmacovigilance Service Provider

EU PHARMACOVIGILANCE SERVICES

QPPV, PSMF & EUDRAVIGILANCE

OUR TECHNOLOGY SYSTEM: ARGUS 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

Request a consultation and speak with our PV experts!

 

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QVIGILANCE BLOG

Explore our latest blog posts

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What you need to know about the ...

25 Sep, 2019

The Good Pharmacovigilance Practice (GVP) Guideline 'Product- or Population-Specific Considerations IV: Paediatric Population' came into effect on 08 November 2018.  It forms part of the European Medicines Agency (EMA) ...

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QPPV and PSMF requirements in case ...

17 Sep, 2019

On 07 August 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the guidance, previously published on 12 March 2019, on the qualified person responsible for pharmacovigilance (QPPV) and ...

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A Guide to the US FDA Safety ...

31 Jul, 2019

To ensure a smooth transition from the pre-authorisation to the post-authorisation phase of the life-cycle of a medicinal product, it is the responsibility of the applicant to have in place a robust Pharmacovigilance ...

Read More