QVigilance
QVigilance is a specialized pharmacovigilance service provider dedicated to ensuring patient safety and regulatory compliance for pharmaceutical companies. They offer comprehensive PV and risk management services, including system setup, case processing, reporting, and consultancy, supporting clients worldwide in meeting EMA, FDA, UK, and other international regulations.
Industries
Nr. of Employees
small (1-50)
QVigilance
Products
Validated safety database and customer portal
A hosted, regulatory‑compliant safety database environment with validated electronic records and a customer portal for document access and management.
Validated safety database and customer portal
A hosted, regulatory‑compliant safety database environment with validated electronic records and a customer portal for document access and management.
Services
Comprehensive ICSR handling and expedited reporting covering receipt, data entry, coding, medical review, quality control and regulatory submission.
Preparation, review and submission of DSURs, PSURs/PBRERs, PADERs and other periodic reports; scheduling and submission to national and central repositories.
Registration and administration of centralised regulatory accounts; submission via regulatory interfaces; monitoring and download of regulatory outputs to support reporting and signal work.
Provision of regional QPPV and local pharmacovigilance contacts; PSMF authoring, review and registration support; local compliance services for regional requirements.
Ongoing or purpose-specific literature searches and review to capture safety signals and ICSRs from published sources.
Signal detection, validation and management in line with GVP guidance, using cumulative data sources and regulatory outputs to prioritise and assess safety signals.
Comprehensive ICSR handling and expedited reporting covering receipt, data entry, coding, medical review, quality control and regulatory submission.
Preparation, review and submission of DSURs, PSURs/PBRERs, PADERs and other periodic reports; scheduling and submission to national and central repositories.
Registration and administration of centralised regulatory accounts; submission via regulatory interfaces; monitoring and download of regulatory outputs to support reporting and signal work.
Provision of regional QPPV and local pharmacovigilance contacts; PSMF authoring, review and registration support; local compliance services for regional requirements.
Ongoing or purpose-specific literature searches and review to capture safety signals and ICSRs from published sources.
Signal detection, validation and management in line with GVP guidance, using cumulative data sources and regulatory outputs to prioritise and assess safety signals.
Expertise Areas
- Pharmacovigilance and safety surveillance
- Clinical case processing and ICSR management
- Regulatory compliance and electronic submissions (EU, UK, US)
- EudraVigilance / EVDAS and XEVMPD administration
Key Technologies
- ICH E2B electronic ICSR XML (R2/R3)
- EudraVigilance interfaces and EVDAS outputs
- XEVMPD / Article 57 product register management
- 21 CFR Part 11 / Annex 11 compliant safety databases
News & Updates
Details on new UK pharmacovigilance requirements post-Brexit, including QPPV and PSMF updates.
Summary of new UK legal obligations for pharmacovigilance following Brexit transition period.
EMA releases draft guidance on pregnancy prevention programmes and risk minimization measures.
Overview of US FDA post-approval pharmacovigilance requirements, including ICSR reporting, periodic reports, and REMS.
Guidance on EU PV system setup, QPPV, PSMF, and signal management for new medicinal products.
Summary of UK draft legislation for medicines, devices, and clinical trials in a no-deal Brexit scenario.
Details on new UK pharmacovigilance requirements post-Brexit, including QPPV and PSMF updates.
Summary of new UK legal obligations for pharmacovigilance following Brexit transition period.
EMA releases draft guidance on pregnancy prevention programmes and risk minimization measures.
Overview of US FDA post-approval pharmacovigilance requirements, including ICSR reporting, periodic reports, and REMS.
Guidance on EU PV system setup, QPPV, PSMF, and signal management for new medicinal products.
Summary of UK draft legislation for medicines, devices, and clinical trials in a no-deal Brexit scenario.