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
The three steps to compliance:
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
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
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
Case Processing & Reporting
QVigilance can meet all your needs for adverse event handling for cases arising from all sources.
Literature Screening
We can run the literature search and review the results, either for specific purposes or for ongoing screening of worldwide literature.
Periodic Reporting
Our team are highly experienced in the delivery of aggregate reports, such as DSURs, PSURs/PBRERs, and PADERs.
Signal Management
QVigilance procedures on on-going and periodic signal detection and management are written in accordance with GVP: Module IX for products both pre- and post-authorisation.
Risk Management
Our team can provide support for additional risk management and risk minimisation activities required for safety concerns.
Regulatory Intelligence
QVigilance actively monitors websites, newsletters, and RSS feeds of regulatory authorities and international standards organisations.
Medical Device Vigilance
QVigilance provides a full range of services for both device clinical studies and post-registration needs
Pharmacovigilance Consultancy
We can provide guidance and support in the development of SOPs working practices supporting pharmacovigilance activities where these are undertaken within your organisation.
EU PHARMACOVIGILANCE SERVICES
QPPV, PSMF & EUDRAVIGILANCE
EU and UK QPPVs
QVigilance can provide an experienced EU QPPV & UK QPPV to support and oversee a client’s portfolio.
EudraVigilance EU QPPV & Trusted Deputy
QVigilance can take on the role of Responsible Person for EudraVigilance for both clinical trial Sponsors or EudraVigilance EU QPPV Trusted Deputy (for MAHs).
Pharmacovigilance System Master File
QVigilance can provide author, review or provide support in preparing a PSMF in preparation for product application/authorisation in the EU.
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.
Client 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!
QVIGILANCE BLOG
Explore our latest blog posts
Pharmacovigilance Outsourcing: Benefits of Working with a Specialist Provider
10 November 2025
Pharmacovigilance (PV) ensures safe and effective use of products throughout their lifecycle. Many sponsors struggle with scale, speed, and consistent oversight across programmes. Want fewer handoffs and clearer accountability? A…
Read More
New PV practice guidance on Pregnancy Prevention Programmes by EMA
28 April 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 released a draft addendum…
Read More
UK Government publishes updated pharmacovigilance guidance for UK medicines
10 September 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…
Read More
Subscribe to our Blog
Get notify when a new piece is out!