Working with Biotech

We help biotechs progress assets efficiently from early development into clinical proof by providing the scientific depth, specialist labs, and operational infrastructure needed to overcome industry‑specific challenges. Our flexible, end‑to‑end model strengthens decision‑making and supports rapid, de‑risked clinical advancement.  

Schedule a Call
hVIVO PK Consultancy Team

  • Over 40 years helping innovative biotechs progress vaccines, antivirals, immunology, respiratory and cardiometabolic assets

  • Integrated capabilities: assay development, biomarkers, early clinical, challenge trials, regulatory guidance

  • Direct access to specialist scientific leaders with deep therapeutic expertise

Speak with our team

We understand the challenges that Biotechs face

  • Resource constraints across assay, clinical, data, and regulatory functions
  • Pressure to meet investor and partnership milestones
  • Increasing biomarker and assay complexity
  • High operational execution risk
  • Regulatory uncertainty at IND, FIH, and challenge model stages
Mannheim Groupes Action & Building 38

Our fully integrated ecosystem supports the pathway for biotech drug developers across scientific strategy, assay development, early clinical execution, and regulatory planning. Work with hVIVO when you:

Have strong science but limited internal infrastructure

Need robust data to support licensing, partnerships, or investment

Require specialist laboratory methods or translational models

Why Biotech Choose hVIVO

Conferences_dark_purple

Deep scientific expertise

Webinar_dark_purple

Integrated laboratory, clinical and scientific infrastructure

14 World Leading Human_dark_purple

World leading Challenge Models

Robotics Automation_dark_purple

Tailored pathways adapted to your resources and milestone needs

Discover our Biotech Solutions

Human Challenge Model Advantage

Use proven challenge trials to generate early efficacy signals and accelerated proof of concept 

Integrated Trial Delivery

End-to-end modular clinical delivery from IND enabling through to Phase III with wrap around functions.


Laboratory Services

 qPCR, ddPCR, serology, immunoassays, NGS, custom assay development. 

Translational Consulting Research

 Bridge R&D to clinic with GLP/GCP ready methods and operational deliver 

Regulatory Support

 Including pre‑IND regulatory advice , and scientific support 

Due Diligence

Due diligence and technical gap analysis 

FAQ

Still have questions?
Get in touch with us
hVIVO works extensively with clinical-stage biotechs that need a scalable, experienced partner to accelerate development timelines. Integrated services, including clinical pharmacology, human challenge trials, regulatory support, medical writing, and laboratory services, help emerging companies progress efficiently through Phase I/II while generating high-quality data to support fundraising, partnering, and regulatory submissions.
Yes. hVIVO’s laboratories routinely develop and validate bespoke virology, immunology, and bioanalytical assays tailored to each programme’s mechanism of action, including custom endpoints, neutralisation assays, qPCR panels, cell-based assays, and exploratory biomarker readouts. Assay development is fully aligned with the sponsor’s regulatory pathway and future clinical needs.
Yes, hVIVO supports a wide range of non-infectious assets, particularly through its Clinical Pharmacology Unit (CPU), which delivers early-phase trials for small molecules, biologics, RNA-based therapies, and advanced modalities. Services include SAD/MAD, food-effect, DDI studies, bioavailability/bioequivalence, PK/PD characterisation, immunogenicity testing, and biomarker-driven studies, even when infectious disease endpoints aren’t required.
Yes, hVIVO’s teams manage both healthy volunteer (HV) and special populations, including renal and hepatic impairment cohorts, elderly cohorts, and women-specific studies. This lets biotech sponsors run more complex, representative trial designs without sourcing these populations independently.
hVIVO is built to address the core pressures clinical-stage biotechs face: resource constraints across assay, clinical, data, and regulatory functions; pressure to hit investor and partnership milestones; growing biomarker and assay complexity; operational execution risk; and regulatory uncertainty at the IND, first-in-human (FIH), and challenge model stages.
hVIVO’s integrated ecosystem spans the full biotech development pathway: the Human Challenge Model for early efficacy signals and accelerated proof of concept, Integrated Trial Delivery from IND-enabling through Phase III, Laboratory Services (qPCR, ddPCR, serology, immunoassays, NGS, custom assay development), Translational Consulting with GLP/GCP-ready methods, Regulatory Support including pre-IND advice, and Due Diligence and technical gap analysis.
Biotechs choose hVIVO for deep scientific expertise, integrated laboratory, clinical, and scientific infrastructure under one roof, world-leading Challenge Models, and pathways tailored to each company’s resources and milestone needs, avoiding the cost and time of building this infrastructure internally.

Contact Us