Team – EUmedra

Our Team

Learn more about the dedicated specialists behind our tailored EU compliance and market-support solutions.

Balázs Bende

A clinical development and translational medicine leader integrating early-phase science, medical governance, and device innovation.

Balázs Bende, MD

Dr. Balázs Bende is a clinical pharmacologist, surgeon and medical director with more than 15 years of experience across early-phase clinical development, ATMP programs, medical device validation, and translational medicine. As CEO of EUMEDRA Integrátor Zrt. and founder of the HCEMM Translational Medicine Research Group, he has overseen over 100 clinical studies, led multidisciplinary teams, established a GxP-integrated academic Phase I Unit, and served as Principal Investigator for first-in-human stem-cell therapy and implantable device trials. His expertise spans oncology, CNS, immunology, vaccines, ATMPs, and IVD/MD performance studies.

Advisory Focus at EUMEDRA:

Early-phase clinical development & FIH/Phase I strategy
Early-phase clinical development & FIH/Phase I strategy
Medical device & IVD clinical validation planning
Translational medicine program design and bench-to-bedside integration
Building clinical operations, GxP-aligned processes & multidisciplinary teams

András Fábri

A cybersecurity and identity-management strategist enabling compliant, secure and scalable digital infrastructures for life-science innovation.

András Fábri

András Fábri is an economic software engineer and cybersecurity specialist with more than a decade of experience in Identity and Access Management (IAM), secure system architecture, and international IT integration projects. As Founder and Director of SCYT Consulting Ltd., he has supported major enterprises in Switzerland, Germany, the UK and Asia, delivering large-scale IAM deployments, cloud integrations, and business-critical security solutions. His expertise strengthens EUMEDRA’s role as a trusted partner for MedTech, digital health and connected-device companies entering the EU market, where cybersecurity, data protection and regulatory-aligned digital architectures are essential.

Advisory Focus at EUMEDRA:

Cybersecurity strategy for medical and digital health technologies
IAM frameworks supporting GDPR-aligned data protection
Digital infrastructure readiness for MDR/IVDR-regulated systems
International business development and EU market-entry facilitation
Strategic partnerships across Switzerland, Germany, the UK and Asia

Dr. Dávid Gulyás

A clinical research strategist combining legal, operational and regulatory leadership to accelerate high-quality trial execution.

Dávid Gulyás, PhD

Dr. Dávid Gulyás is a lawyer and healthcare manager with extensive experience leading complex Phase I–IV clinical trials across multiple therapeutic areas. As CEO of one of the region’s largest site networks, he brings a unique dual perspective that integrates legal strategy, operational excellence and regulatory compliance, ensuring high-performing, risk-controlled clinical development pathways.

Advisory Focus at EUMEDRA:

Shaping regulatory and operational strategy for clinical development programmes
Strengthening legal and contractual structures for sponsors and partners
Building high-performing site and investigator ecosystems
Advising on partnership models and network development
Supporting trial feasibility, implementation frameworks and quality assurance

István Boglárka

A clinical research operations expert uniting medical insight with high-performance site management.

István Boglárka, MD

Dr. István Boglárka is an experienced neurologist and clinical research leader with over two decades of hands-on involvement in study execution, feasibility assessment, monitoring, and regulatory coordination. His background spans pharmaceutical, medical device, and biotechnology studies, providing a highly practical and operations-focused perspective essential for reliable clinical development.

Advisory Focus at EUMEDRA:

Péter Kovács

A strategic clinical development architect and international life‑science investor uniting scientific rigor, operational excellence and business strategy to build successful biotech and medtech programs.

Péter M. Kovács, PhD

Dr. Péter Kovács is a seasoned clinical research executive, Dr.Pharm., MSc., MBA, Ph.D., with more than two decades of global experience in drug development, research planning, Phase I–III clinical operations, and biotech/medtech investment. His career spans leadership roles in CROs, global pharma, academic centers, and international clinical research organizations. He is the founder of multiple clinical research companies and investor groups operating across Europe, South‑East Asia and the United States. His unique strength lies in combining clinical execution expertise with strategic financing and company‑building.

Advisory Focus at EUMEDRA:

Integrating regulatory, clinical and business strategy for development programs
Supporting early‑stage companies in clinical readiness and investor alignment
Building scalable clinical infrastructures and site‑network models
Advising on technical‑risk elimination and accelerated evidence generation
Strengthening global partnership ecosystems for biotech/medtech programs

Dr. Tibor Pankotai

A translational research and molecular diagnostics leader uniting deep scientific expertise with regulatory innovation and commercialization strategy.

Tibor Pankotai, PhD

Dr. Tibor Pankotai is a molecular biologist, cancer researcher, and laboratory systems architect with extensive expertise in DNA repair, genomic instability, liquid-biopsy diagnostics, and molecular pathology. He has founded and led multiple high-impact molecular laboratories—including COVID-19 and molecular pathology units—and has shaped national diagnostic regulation through his published molecular pathology framework. His portfolio spans next-generation sequencing, bioinformatics, regulatory strategy, and ISO-based laboratory implementation, complemented by commercialization experience strengthened through an MBA.

Advisory Focus at EUMEDRA:

Regulatory and scientific strategy for molecular diagnostics and oncology assays
Design and operation of ISO-regulated molecular laboratories
NGS, liquid-biopsy and precision oncology workflows
Translational research integration and biomarker development
Commercialisation pathways for diagnostic technologies

Dr. Zsuzsanna Papp

A biostatistics and quality systems expert ensuring data integrity, regulatory compliance, and operational excellence across clinical and non-clinical research.

Zsuzsanna Papp, PhD

Dr. Zsuzsanna Papp is a life‑science quality and data expert with more than three decades of experience in biostatistics, clinical and non‑clinical data management, and GxP‑compliant quality systems. As Managing Director of Adware Research, she has led the development of integrated GLP, GCP, ISO 9001 and ISO 17025 frameworks, coordinated audits, supervised study processes, and supported statistical and documentation structures for clinical and toxicological research. She brings a rare combination of scientific rigor, regulatory mastery, and operational leadership.

Advisory Focus at EUMEDRA:

Regulatory strategy and GxP‑aligned quality system development
Clinical and non‑clinical data integrity, statistics, and methodology support
Study design, protocol structure, and documentation frameworks
Audit readiness, CAPA management and quality risk mitigation
Operational efficiency and project governance for R&D organizations

Szabolcs Tóth, RA/QA Consultant

A regulatory and quality architect enabling compliant, efficient and scalable medical device development.

Szabolcs Tóth, MBA

Szabolcs Tóth is a regulatory and quality systems expert specialising in medical software and medical devices, with extensive experience designing compliant development frameworks and regulatory submissions.

Advisory Focus at EUMEDRA:

Zoltán László Tóth

A regulatory, quality, and risk‑management expert enabling compliant, efficient, and audit‑ready medical device development.

Zoltán László Tóth

Zoltán László Tóth is a freelance medical device consultant and lead auditor specializing in ISO 13485, FDA QSR 21 CFR 820, MDR/IVDR and GMP compliance. He supports companies across Class I–III devices and pharmaceutical technologies, guiding them through regulatory submissions, technical documentation, supplier qualification, and quality‑system implementation. With experience in R&D, NPI, multilingual documentation and international device programs, he brings a practical yet highly regulatory‑aware approach to the entire product lifecycle.

Advisory Focus at EUMEDRA:

Regulatory strategy and compliance frameworks (ISO 13485, FDA 21 CFR 820, MDR/IVDR, GMP)
Quality management system development and optimization
Technical documentation and regulatory submission support
Supplier qualification, audit preparation and audit readiness
Risk‑based process design and product lifecycle QA oversight

Dr. Kálmán Törőcsik

A clinical research innovator advancing decentralized trial models, regulatory strategy, and high-performance CRO operations across Europe.

Kálmán Törőcsik, MD

Dr. Kálmán Törőcsik is a medical doctor and clinical research executive with more than a decade of experience integrating CRO leadership, regulatory strategy, and patient‑centric clinical trial delivery. As President of the Hungarian Clinical Trial Management Society (MKVT) and leader of multiple healthcare and research organizations, he brings a dual perspective spanning both clinical operations and healthcare provider ecosystems. His expertise includes decentralized and hybrid trial models, EU CTR implementation, device and drug development pathways, and strategic site‑network development.

Advisory Focus at EUMEDRA:

Regulatory strategy and EU market entry planning
Clinical development support for early‑phase drug and medical device programs
Decentralized and hybrid clinical trial integration
Quality management frameworks for CROs and clinical operations
Scaling operational capabilities and ecosystem partnerships across CEE and EU

Management

Balázs Bende, MD

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