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.  

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Project teams

  • 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

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We understand the challenges that Biotechs face:

1. Resource constraints across assay, clinical, data, and regulatory functions

2. Pressure to meet investor and partnership milestones

3. Increasing biomarker and assay complexity

4. High operational execution risk

5. Regulatory uncertainty at IND, FIH, and challenge model stages

 


 

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

Strong science but limited internal infrastructure

  • Need robust data to support licensing, partnerships, or investment

  • Require specialist laboratory methods or translational models

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 

Why Biotech Choose hVIVO

  • Deep scientific expertise
  • Integrated laboratory, clinical and scientific infrastructure
  • World leading Challenge Models
  • Tailored pathways adapted to your resources and milestone needs
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FAQ

Still have questions?
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We work extensively with clinical‑stage biotechs who need a scalable, experienced partner to accelerate their development timelines. Our 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 that supports fundraising, partnering, and regulatory submissions.
Yes.
Our laboratories routinely develop and validate bespoke virology, immunology, and bioanalytical assays tailored to each programme’s mechanism of action. We can create custom endpoints, neutralisation assays, qPCR panels, cell‑based assays, and exploratory biomarker readouts. Assay development is fully aligned with your regulatory pathway and future clinical needs. 
Yes — we support a wide range of non‑infectious assets, particularly through our Clinical Pharmacology Unit (CPU), which delivers early‑phase trials for small molecules, biologics, RNA‑based therapies, and advanced modalities. Our services include SAD/MAD, food‑effect, DDI studies, bioavailability/bioequivalence, PK/PD characterisation, immunogenicity testing, and biomarker‑driven studies, even when infectious disease endpoints are not required.
Yes — our teams manage both HV and special populations including renal/hepatic impairment, elderly cohorts, and women specific studies.

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