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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What We Do

Expertise across the full
development lifecycle

Vivio turns deep scientific, regulatory, and commercial expertise into practical decisions that move a programme forward, from first concept through to regulatory submission. Every engagement is grounded in the standards and frameworks your markets actually run on.

Regulatory Consulting

A clear regulatory route is the difference between a programme that moves and one that stalls. We define the pathway early for advanced therapies, biologics, and biosimilars, then manage the regulator conversations that keep it on track. With Türkiye's 2023 advanced-therapy regulation now mirroring the EU framework, and TITCK a member of both ICH and PIC/S, Vivio works as your bridge across the Turkish, European, and US systems.

  • Market-entry and submission strategy for cell, gene, and biologic therapies
  • Scientific advice and briefing packages with TITCK, EMA, and FDA
  • GLP, GMP, GCP, and GDP compliance and inspection readiness
  • Alignment to current ICH standards, including the modernised E6(R3) good clinical practice guideline
TITCK EMA FDA ICH

Quality Systems

Regulators and partners want to see systems they can trust. We build and audit quality management systems to the standards your market expects, from a laboratory's first accreditation to a manufacturer's full quality system. As the FDA aligns its device rules with ISO 13485 in 2026, well-built systems now carry further across borders than ever.

  • Laboratory accreditation to ISO/IEC 17025 and biobanking to ISO 20387
  • Medical-device quality systems to ISO 13485 and biological safety to ISO 10993
  • Procedures, documentation, and validation that hold up to inspection
  • Internal audits and readiness assessments
ISO FDA QMSR

Grant Strategy

Non-dilutive funding can carry a programme through its riskiest years. We shape the concept, build the consortium, and write to win, then manage delivery once the award lands. From Horizon Europe and the European Innovation Council to Türkiye's TÜBİTAK and TÜSEB, we know how evaluators read a proposal and where scores are won and lost.

  • Proposals for Horizon Europe, the EIC (Pathfinder, Transition, Accelerator), and the ERC
  • Turkish national funding through TÜBİTAK and TÜSEB
  • Consortium building, budget design, and work-package structuring
  • Project and financial management after the award
Horizon Europe EIC TÜBİTAK

Preclinical Study Design

Preclinical work should build the strongest possible case for your therapy while making every study count. We design regulator-ready programmes for biologics and advanced therapies, and we lead on new approach methodologies, the non-animal methods that regulators are now actively encouraging. In 2025 the FDA set out a roadmap to reduce animal testing, beginning with monoclonal antibodies, and we help clients get ahead of it.

  • GLP study design and monitoring under OECD and FDA principles
  • New approach methodologies (NAMs) and weight-of-evidence strategies
  • Bioanalytical method development and validation
  • Characterisation strategies for antibodies and cell and gene therapies
OECD FDA NAMs ICH

Translational Programme Management

Getting from discovery to the clinic means keeping science, regulation, and timelines moving together. We provide the oversight that turns a promising asset into an IND-ready package, sequencing studies to avoid late surprises and keeping every partner pulling in the same direction.

  • End-to-end oversight from discovery to IND-enabling studies
  • Target product profiles, milestones, and stage-gated portfolio strategy
  • Risk management and study sequencing
  • Coordination across partners, vendors, and CROs
FDA ICH

Business Development Support

Good science still has to make a commercial case. We help teams value their assets, run diligence, and tell the story that partners and investors need to hear, grounded in the data rather than the hype.

  • Asset valuation using risk-adjusted NPV and comparable deals
  • Technical, IP, regulatory, and commercial due diligence
  • In-licensing and out-licensing strategy and partner search
  • Investor and partnering materials, and market analysis
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
LinkedIn ORCID iD

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, with 8 peer-reviewed publications

Our Team

Growing the Vivio team

Vivio is expanding its consulting bench to broaden the scientific and regulatory expertise we bring to client programmes. Two consultants are joining the team, with profiles to be announced shortly.

New Consultant

Profile to be announced

An additional consultant is joining Vivio to strengthen our capacity across science and regulatory strategy. Full profile to follow.

New Consultant

Profile to be announced

An additional consultant is joining Vivio to strengthen our capacity across science and regulatory strategy. Full profile to follow.

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