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

 

 

Submit an RFI  Case Study

The three steps to compliance:

icon_Submit RFI_v2

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
icon_parnter_v2

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
icon_compliance

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.

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!

 

Submit an RFI

QVIGILANCE BLOG

Explore our latest blog posts

5977730031

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

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 ...

Read More

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 ...

Read More