Biotech Consultancy & Preclinical CRO

Science-led strategy.
Built from experience.

Vivio is a boutique biotech consultancy and emerging preclinical CRO that bridges scientific R&D, regulatory affairs, and commercial strategy. Founded by someone who has built the facilities, designed the programmes, written the grants, and led the consortia we consult on.

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20+
Years Experience
€19.6M
Grants Coordinated
What We Do

Expertise across the full
development lifecycle

From early-stage R&D through regulatory submission, Vivio provides the strategic and technical capabilities that emerging biotech companies need to advance their programmes.

Regulatory Consulting

GLP, GMP, GCP, and GDP compliance strategy. Regulatory pathways for ATMPs, biologics, and biosimilars across TITCK, EMA, FDA, and ICH frameworks.

GLP/GMP/GCP ATMPs EMA/FDA

Quality Systems

End-to-end ISO implementation and auditing — 17025, 20387, 10993, 13485. SOPs, validation protocols, and internal audit programmes.

ISO 17025 ISO 13485 Validation

Grant Strategy

Proposal writing, consortium assembly, and budget design for Horizon Europe, ERC, EIC, TÜBİTAK, and TÜSEB programmes. Full project management post-award.

Horizon Europe ERC/EIC TÜBİTAK

Preclinical Study Design

GLP study protocols, NAM integration, animal study design, bioanalytical method development, and characterization strategies for mAbs and ATMPs.

GLP Studies NAMs Bioanalysis

Translational Programme Management

End-to-end oversight from discovery through IND-enabling studies. Portfolio strategy, milestone tracking, and risk management for complex pipelines.

IND-Enabling Portfolio Risk Mgmt

Business Development Support

Technology due diligence, licensing strategy, investor presentations, and market analysis for biotech assets. Connecting science to capital.

Due Diligence Licensing Market Analysis
Track Record

Programmes designed,
built, and delivered

From biologics and advanced therapies to GLP facility management and multinational grant coordination — selected programmes that demonstrate our depth and range.

Biologicals

Bispecific Antibodies & Biosimilar Programmes

Designed BİSAN — Türkiye's first bispecific therapeutic antibody programme. Led biosimilar development programmes for cetuximab and adalimumab, covering analytical characterization, regulatory strategy, and preclinical study design across the full development lifecycle.

Advanced Therapy Medicinal Products

iPSC-Derived Hypoimmunogenic Cell Therapies

Designed translational programmes for allogeneic iPSC-derived hypoimmunogenic cell therapies, including CAR-T (CD19), CAR-Tregs, CAR-Bregs, CAR-DCs, beta cells, and iHEP (induced hepatocytes). End-to-end ATMP platform design from cell engineering through preclinical characterization.

Non-Clinical Study Design

GLP Preclinical Facility & Study Design

Founding facility manager of Türkiye's first GLP-certified preclinical testing laboratory (IBG DACL, Izmir Biomedicine and Genome Center). Designed the preclinical study programme for an eculizumab biosimilar and provided consultancy on the non-clinical study design of more than 10 molecules.

Multinational Grants

EU & International Consortium Coordination

VANGUARD — Horizon Europe (Coordinator, €6.7M, 7 partners, 5 countries)
UniTol — Horizon Europe (Coordinator, €9.9M, 8 partners, 5 countries)
HoliDC — EIC Pathfinder (Coordinator, €3.0M, 4 partners, 3 countries)

Published in peer-reviewed journals
including Nature Communications and FASEB Journal
8
Publications
Founder

Led by someone who has done
everything we consult on

Soner Gündemir, PhD
PhD Pharmacology MFin Corp. Finance

Soner Gündemir, PhD

Founder & CEO · Vivio Research & Consultancy

Over twenty years of experience spanning the United States, United Kingdom, and Türkiye — from biologics and biosimilar development to ATMP platform design, GLP facility construction, non-clinical study design for over 10 molecules, and coordination of multinational EU-funded consortia.

Soner holds a PhD in Pharmacology from the University of Rochester and a Master of Finance in Corporate Finance from Sabancı University (with A.T. Kearney). This dual background in deep science and structured commercial thinking defines Vivio's approach: rigorous, strategic, and grounded in real-world execution.

Founding facility manager of Türkiye's first GLP-certified preclinical testing laboratory (IBG DACL)

Designed Türkiye's first bispecific therapeutic antibody programme (BİSAN)

ATMP platform design for iPSC-derived CAR-T, CAR-Tregs, CAR-DCs, beta cells, iHEP

3 EU consortia coordinated — VANGUARD, UniTol, HoliDC (€19.6M total)

Non-clinical study design consulted on 10+ molecules including eculizumab biosimilar

Published in Nature Communications, FASEB Journal — 8 peer-reviewed publications

Get in Touch

Let's discuss your programme

Ready to move forward?

Whether you're planning a regulatory submission, building a preclinical programme, assembling an EU consortium, or exploring a CRO partnership — we'd welcome the conversation.

Email
gundemir@vivioresearch.com
Phone
+90 (533) 668 5950
Location
Istanbul, Türkiye