Pharmacovigilance & Regulatory Compliance

Built to catch the signal
before it becomes a risk.

VIGIVANCE builds and runs pharmacovigilance departments for pharmaceutical, medical device, and cosmetic companies — end to end, or exactly where you need us.

Live signal monitor ICSR · Case #04471
Signal detected · routed for medical review 00:00:42
40+Countries served
8PV departments built from the ground up
15+GVP audits supported
4Vigilance domains covered
What we do

Four disciplines, one accountable partner

From individual case processing to full regulatory strategy — each service stands alone, or works together as a complete outsourced department.

Pharmacovigilance

End-to-end ICSR management, QPPV/LQPPV support, PSMF, signal management, and safety writing.

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Regulatory Affairs

Product registration, renewals, dossier compilation, labeling, and MAH obligation support.

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Clinical Support

Site identification, investigator training, GCP compliance, monitoring, and PMS study support.

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Medical Writing

Clinical, technical, and regulatory documentation, plus safety reports and aggregate reviews.

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Why VIGIVANCE

Depth without the overhead of building it yourself

Founded on healthcare expertise

Built by an experienced healthcare professional, backed by medical experts, pharmacology specialists, and industry professionals with decades of combined experience.

Two flexible engagement models

Complete services outsourcing when you need a full department, or customized client-specific services when you need targeted support.

Global regulatory reach

Active support across Europe, CIS, Asia, MENA, GCC, Africa, and LATAM — keeping MAHs, manufacturers, and distributors compliant everywhere they operate.

Ready to strengthen your safety oversight?

Tell us where you are today — from first PV department to full GVP audit readiness.

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