Regulatory Intelligence in Pharmacovigilance
As part of our ongoing regulatory intelligence activities,
QVigilance team actively monitors websites, newsletters,
and RSS feeds of regulatory authorities and international
standards organisations; as well as reviewing
relevant articles and blogs
Ongoing Monitoring Services
QVigilance continuously monitors regulatory information from local, regional and global authorities and organisations for pharmacovigilance-related regulatory intelligence to ensure that we and our customers are always up to speed and thereby maintain compliance with the latest regulatory requirements and guidelines for both investigational and authorised products.
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Risk Management Services
Regulatory Update
Advice on pharmacovigilance regulations and guidance in individual countries
Case Reporting
Maintaining country-specific and regional case reporting requirements
Aggregate Reporting
Maintaining country-specific and regional periodic/aggregate reporting requirements
QPPV
Support on Local QPPV/representative/safety affiliates requirements globally
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Get in touch with our experts!
The Role of a Centralised Safety Database in Clinical Trials and Post-Marketing PV
28 January 2026
For decades, there has been a requirement to record, analyse, and report safety data to health authorities. With the recent improvements and shifts in approach, such as the updated GCP guidelines, parties involved…
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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…
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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…
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