HorizonWörwag PharmasantherainsifeTimberlinePerennial PharmaPRA Health ScienceEver Pharma
HorizonWörwag PharmasantherainsifeTimberlinePerennial PharmaPRA Health ScienceEver Pharma
Viginext Logo White

Building a
Resilient Vigilance Ecosystem

Integrated Advisory and Auditing for Human,
Animal, and Cosmetic Safety.

Free Initial Consultation
Free Initial Consultation
370+
Audits Delivered
10+ years
Human and Veterinary Health
100%
Vendor-Neutral. Always.

VIGINEXT is a specialist pharmacovigilance advisory and GxP audit firm. We work exclusively with pharmaceutical and biotech companies navigating the regulatory demands of drug safety, from first clinical submissions through commercial phase

The Founders

Independent pharmacovigilance leadership for small and mid-size pharma and biotech.

Free Initial Consultation
Free Initial Consultation
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Building PV systems for whatever situation put them under strain.

Stefan Brüning
Co-Founder and Consulting Practice Lead
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Responsible for leading human health and veterinary PV audits to help organisations build robust, inspection-ready PV systems.

Janine Gavin
Co-Founder and Audit Practice Lead
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“Pharmacovigilance is a fundamental responsibility to patients, not just a regulatory checkbox. We make sure your systems reflect that.”

Stefan Brüning
Dipl.Biol., MBA, PMP, MRQA Co-Founder

“Solid compliance is built before the auditor knocks. We help you get there — and stay there.”

“Pharmacovigilance is a fundamental responsibility to patients, not just a regulatory checkbox. We make sure your systems reflect that.”

Stefan Brüning
Dipl.Biol., MBA, PMP, MRQA Co-Founder

“Solid compliance is built before the auditor knocks. We help you get there — and stay there.”

Combined Expertise

Meet our Team

All Experts
All Experts

Ideal Clients

Its a match when one of these fits to your situation:
Pharmaceutical and Biotech Companies Pre-MAA and building their first PV system
Pharmaceutical and Biotech Companies Preparing for commercial launch
Pharmaceutical and Biotech Companies Post-marketing and optimising what exists
Growing organisation through M&A

See our Main Areas of Expertise

Contact us directly if there are any questions

Questions?

Let's talk

Have a question or want to talk through your project?
Reach out and our team will get back to you shortly.

Contact
Contact

FAQ

Your specific question is not here? Ask us anything!

Free Initial Consultation
Free Initial Consultation
Do you work with companies our size, or mainly with large pharmaceutical companies?
Do you only conduct audits, or do you also help fix what the audit finds?
Are you tied to a specific safety database or software vendor?
Will the same person handle our engagement from start to finish?
How quickly can you start if we already have an inspection date?
How is an engagement scoped and priced?
Why work with a boutique firm instead of a large consultancy?

Blog and articles

Latest insights and pharma trends

Explore our latest articles and expert insights.

All Articles
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QPPV, Governance, Inspection Readiness, Management

You appointed a QPPV. The responsibility stayed with you.

Under EU law, the QPPV takes over pharmacovigilance tasks while resources, oversight and audits stay with management. In small and mid-sized companies, this usually surfaces at an inspection or an acquisition.

Stefan Brüning
6 minutes
Interesting

Surviving the PV Growth Trap: A Blueprint for Overwhelmed Safety Leaders

Rapid expansion through acquisition or market entry is a significant risk factor for pharmacovigilance (PV) systems in small and medium-sized enterprises.

Stefan Brüning
5 min read
Congress

DIA Europe Annual Meeting 2026

The DIA Annual Meeting is a great chance to step back from daily operations and talk about where our industry is headed.

Stefan Brüning
5 min read
Safety

Why Biotech and Pharma Companies Need Independent Safety Systems for Clinical Trials

Biotech and pharmaceutical companies planning clinical development programs face a critical strategic decision:

Stefan Brüning
9 min read
QPPV, Governance, Inspection Readiness, Management

You appointed a QPPV. The responsibility stayed with you.

Under EU law, the QPPV takes over pharmacovigilance tasks while resources, oversight and audits stay with management. In small and mid-sized companies, this usually surfaces at an inspection or an acquisition.

Stefan Brüning
6 minutes
Interesting

Surviving the PV Growth Trap: A Blueprint for Overwhelmed Safety Leaders

Rapid expansion through acquisition or market entry is a significant risk factor for pharmacovigilance (PV) systems in small and medium-sized enterprises.

Stefan Brüning
5 min read
Congress

DIA Europe Annual Meeting 2026

The DIA Annual Meeting is a great chance to step back from daily operations and talk about where our industry is headed.

Stefan Brüning
5 min read
Safety

Why Biotech and Pharma Companies Need Independent Safety Systems for Clinical Trials

Biotech and pharmaceutical companies planning clinical development programs face a critical strategic decision:

Stefan Brüning
9 min read
Viginext Logo White
Building a Resilient Vigilance Ecosystem.
Pharmacovigilance
GVP Auditing and Inspection Readiness
Veterinary PV
Medical Information
Cosmetovigilance
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Three healthcare workers in scrubs taking a break and talking in a sunlit hospital hallway with large windows.
Modern office building with large glass windows reflecting its interior, showing orange letters spelling MAFINEX.