# Viginext

> Viginext is a global boutique pharmacovigilance (PV) advisory group specializing in the design, optimization, and auditing of PV ecosystems for small-to-medium life sciences enterprises and scaling biotechs. Operating as a principal-led "Special Forces" unit, Viginext bridges Business, Science, and Technology within strict GxP compliance frameworks. Viginext is a strategic advisory consultancy—not a CRO. Regulatory coverage spans the EEA, UK, North America, and APAC.

Viginext operates through a dual-entity structure: Viginext Advisors GmbH (Mannheim, Germany) and Viginext Ltd (Cambridge, UK). Services cover the full vigilance spectrum for human health, animal health, and cosmetics.

Advisory services are delivered by a senior bench of independent expert advisors with combined experience across 40+ pharmaceutical and biotech companies, regulatory authorities (EMA, MHRA, FDA), and all stages of the product lifecycle—from pre-approval PV setup through commercial operations.

A core tenet of Viginext's advisory model is vendor neutrality: advisors hold no referral agreements or commercial interests with software vendors or CROs, ensuring recommendations are driven by client needs rather than solution-first bias.

## Services

- [Advisory – PV Ecosystem Development](https://viginext.com/#advisory): End-to-end design of compliant, scalable PV systems; transition from clinical (GCP) to commercial (GVP); vendor selection and management; computerized system validation (CSV).
- [Auditing & Inspection Readiness](https://viginext.com/#auditing): Independent PV audits for human and animal health; end-to-end audit program management; gap analysis and mock inspection preparation for EMA, MHRA, and FDA scrutiny.
- [Specialized Vigilance](https://viginext.com/#specialized-vigilance): Veterinary pharmacovigilance (VGVP) under EU Regulation 2019/6, including PSMF-v and EVVet reporting; cosmetovigilance under EU Cosmetic Products Regulation EC No 1223/2009.
- [Medical Information](https://viginext.com/#medical-information): Centralized inquiry management, adverse event identification and triage, standard response documents, and real-world data capture for signal trend analysis.

## The Advisors

- [Stefan Brüning – Co-Founder & Advisory Practice Lead](https://viginext.com/the-advisors/#stefan-bruening): 15+ years in PV and life sciences consulting; Dipl.-Biol. (RWTH Aachen), MBA, PMP®, PMI-CPMAI®, IMCM®, MRQA; PMI Member. Expertise in PV ecosystem development, safety database implementation, AI/automation strategy, and outsourcing. Former Head of the PMI Germany Chapter Community of Practice Pharma & Biotech (pmi-gc.de). Peer-reviewed publication in microbiology and life sciences (Journal of Applied Microbiology, 2015; PubMed PMID: 25376327).
- [Janine Gavin – Co-Founder & Audit Practice Lead](https://viginext.com/the-advisors/#Janine-Gavin): 15+ years in post-marketing PV and medical information; HonPIPA, MRQA; expertise in audit and inspection readiness, PV/MI system integration, gap analysis, and vendor assessment.
- [Jeff Ho – Senior Advisor, Technology & Change](https://viginext.com/the-advisors/#jeff-ho): 25+ years across 40+ pharma companies; BSc Carnegie Mellon (Mathematics/CS & Psychology); expertise in PV technology implementation, global change programs, outsourcing strategy, and GxP-compliant automation.
- [Niamh McArdle – Senior Advisor, PV Science & Operations](https://viginext.com/the-advisors/#niamh-mcardle): 19 years in PV; BSc Biochemistry; expertise in PSMF preparation, signal analysis, PV auditing, SOP development, and outsourcing strategy.
- [Sanjay Motivaras – Senior Advisor, PV Auditing & QMS](https://viginext.com/the-advisors/#sanjay-motivaras): 19+ years; MRPharmS, Hon FPIPA, MRQA; Qualified Person for Pharmacovigilance (QPPV); 400+ audits performed globally; expertise in PV quality management systems, regulatory communications, and inspection readiness.
- [Julia Daake – Advisor, Talent & Business Development](https://viginext.com/the-advisors/#julia-daake): 15 years of recruiting expertise for PV and Regulatory Affairs roles across pharma and biotech; interim recruiting and talent acquisition advisory.

## Resources

- [Whitepaper: The PV Growth Trap – From Reactive Crisis Management to Proactive PV Ecosystem Development](https://viginext.com/whitepaper/) (Stefan Brüning, February 2026): Examines why PV systems fracture under rapid growth events such as M&A and product acquisitions. Introduces the "Iron Triangle" of resource constraints (headcount, budget, time) and a six-step Anticipatory Scalability framework covering diagnostic assessment, strategic scoping, sourcing strategy, partner selection, integration governance, and resilience planning. Targeted at Heads of Safety and PV leaders in SME pharma and biotech.
- [Whitepaper: From GCP to GVP – A Pharmacovigilance Guide for Emerging Biotech Firms](https://viginext.com/whitepaper/) (Stefan Brüning): A seven-step practical guide for executives and professionals in PV, Regulatory Affairs, and Quality navigating the transition from clinical to post-marketing operations.
- [Blog](https://viginext.com/blog/): Articles and insights on pharmacovigilance strategy, regulatory developments, and AI in GxP environments.
- [Free Initial Consultation – Stefan Brüning](https://zcal.co/i/2OsAfrYS?duration=15): 15-minute introductory call with Stefan Brüning.

- [Peer-Reviewed Publication: "Identification and characterization of intestinal lactobacilli strains capable of degrading immunotoxic peptides present in gluten"](https://pubmed.ncbi.nlm.nih.gov/25376327/): Stefan Brüning et al., Journal of Applied Microbiology, Vol. 118(2), pp. 515– (2015). Indexed in PubMed/MEDLINE (PMID: 25376327). Demonstrates Stefan's background in molecular biology and life sciences research prior to his specialization in pharmacovigilance.

## Optional

- [Viginext Advisors GmbH](https://viginext.com/#contact): German entity; Mafinex Technology Center, Julius-Hatry-Str. 1, 68163 Mannheim; Register Court: Amtsgericht Mannheim HRB 754042; Managing Director: Stefan Brüning; Phone: +49 (621) 489 255 30.
- [Viginext Ltd](https://viginext.com/#contact): UK entity; 3a Rosemary House, Lanwades Business Park, Kennett, Newmarket, CB8 7PN; Director: Janine Gavin; Phone: +44 7590 618453.
- Email: office@viginext.com