Pharmaceutical regulatory expertise and leadership development for organisations that take both compliance and their people seriously.
What We Do
End-to-end regulatory compliance support including ICSR processing, safety reporting, PSUR/PBRER authoring, and QPPV support.
Executive coaching and leadership development for organisations navigating change, retaining talent, and building lasting culture.
Fidus PV Consulting kft. is a dual-speciality consultancy operating at the intersection of pharmaceutical regulatory affairs and leadership development.
Fidus PV Consulting kft. was founded on a simple conviction: that organisations performing at the highest level need two things to be working simultaneously — regulatory integrity and people who are genuinely equipped to lead.
Our pharmacovigilance practice helps pharmaceutical companies and sponsors meet their regulatory obligations with precision and confidence. From individual case safety reports to periodic benefit-risk evaluation reports, we provide the expertise that keeps organisations compliant, audit-ready, and protected.
Our leadership practice — delivered under the ELOMI brand — addresses the human side of organisational performance. We work with executives, founders, and leaders at every level to build the self-awareness, communication, and strategic presence needed to lead through change, retain talent, and build cultures that last.
Together, these two service lines reflect what we believe about organisations: that compliance and culture are not competing priorities. They are both foundations. And both require expert, sustained investment.
We provide expert pharmacovigilance and regulatory support for pharmaceutical companies, sponsors, and clinical research organisations. Our work ensures that your safety obligations are met accurately, consistently, and on time — so you can focus on what matters most.
Individual Case Safety Report processing and submission in compliance with ICH E2B guidelines and regional regulatory requirements. Rigorous triage, assessment, and timely filing to ensure your pharmacovigilance system remains audit-ready at all times.
Comprehensive safety reporting across all phases of the product lifecycle. We handle expedited and periodic reporting obligations with the accuracy and regulatory knowledge needed to meet authority expectations globally.
Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports authored to the highest standard. Our approach ensures a rigorous, evidence-based benefit-risk analysis that stands up to regulatory scrutiny and reflects your product's safety profile accurately.
Qualified Person for Pharmacovigilance support services, providing the expertise and oversight your pharmacovigilance system requires. We work alongside your team to ensure your PSMF, signal management, and regulatory interactions are managed effectively and compliantly.
ELOMI is Fidus's leadership development and executive coaching practice — built for organisations that understand their greatest competitive advantage is not their technology. It is their people.
Most organisations invest in leadership for the top tier and leave everyone else to figure it out. ELOMI exists to change that — with coaching and development programmes that reach across the organisation.
One-to-one coaching for senior leaders, founders, and executives navigating transitions, growth, or the challenge of leading at a higher level of complexity. We work on identity, presence, decision-making, and the personal brand that defines how others experience your leadership.
Structured development programmes for leaders and managers at all levels. Built around the ELOMI framework — covering leadership identity, vision, communication, and the emotional tools needed to lead through change with confidence and clarity.
Supporting organisations through periods of transformation — including AI integration, restructuring, and cultural shifts. We equip leaders and teams with the mindset, skills, and frameworks needed to navigate uncertainty without losing trust, morale, or talent.
Working with organisations to build the leadership culture and development infrastructure that makes people want to stay. We address the root causes of disengagement and turnover — not just their symptoms — so retention improves sustainably.
Take the ELOMI Wheel of Life Assessment — a 5-minute self-evaluation across eight dimensions of leadership and life. Your results reveal exactly where to focus first.
Whether you have a pharmacovigilance challenge, a leadership development need, or simply want to explore how Fidus can support your organisation — we would like to hear from you.
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