Remain compliant and safeguard your patients

As Pharmacovigilance Service Provider we can meet all your clinical trial and post-authorisation needs!

 

 

Submit an RFI         Contact Us

The three steps to compliance:

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Submit an RFI >

  • 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 E2B-R3 ready validated Oracle Argus 8.1 system which is compliant with the latest reporting requirements. We also provide our iQ customer portal where documents can be easily accessed and managed.

Request a consultation and speak with our PV experts!

 

Submit an RFI

QVIGILANCE BLOG

Explore our latest blog posts

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QPPV and PSMF requirements update ...

19 Mar, 2019

On 12 Mar 2019, Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) if the UK ...

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MHRA e-Submission Update in ...

06 Mar, 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) have released guidance on how to make regulatory submissions for all regulatory and periodic vigilance submissions. This will include clinical trial ...

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Health Canada: Discontinuation of ...

05 Mar, 2019

On 30th Jan 2019, Health Canada issued a notice that effective from 01st April 2019, it will discontinue issuing acknowledgment letters for regulatory activities submitted by the Sponsors. These regulatory activities ...

Read More