Our Expertise
Together with sponsors, we shape efficient, milestone‑driven development programmes that move science forward. With broad therapeutic expertise, we help teams reduce uncertainty, refine programme strategy and reach the clinic faster.
- Decades of experiences in authoring drug/product development plan, supporting start-ups to progress with fundraising and subsequently guiding their programme.
- Over 150 technical due diligence and gap analysis projects, supporting both investors/acquirers and start-ups across CMC, nonclinical, clinical and regulatory domains.
- Extensive non-clinical expertise in managing and monitoring all toxicology, PK/TK and metabolism (ADME) studies end-to-end. Accredited to perform PK/TK evaluations under GLP compliance.
- Delivering industry‑standard clinical pharmacology expertise, that drives confident, accelerated decision‑making throughout early and late clinical development (500+ PK/PD studies delivered in recent years, with >97% on time delivery).
- Net Promoter Score 9.78 – excellent client satisfaction
- Experience in EMA PRIME and FDA Fast Track Designation , supporting medicines for unmet needs through early dialogue and scientific advice.
Our Investor Readiness Solution
- Strategic guidance informed by decades of real‑world drug‑development and due‑diligence experience.
- Development or refinement of core investment‑critical documents: TPP, DDP, and Regulatory Roadmap.
- Flexible expert resourcing to strengthen your internal team when needed.
- Mock due‑diligence reviews and comprehensive gap analysis across scientific, clinical, operational, and regulatory domains.
- Analytical and clinical development forecasting with scenario‑based budgeting.
- Clinical development strategy design, financial modelling, and budget planning.
- A pitch ready deck ready to present to investors.
Our Services
Clinical
hVIVO supports the full journey from preclinical to Phase III, transforming early Phase I data into clear direction for your product’s next steps. We enable fast success — or fast, informed failure — so you can make smarter decisions sooner.
Our integrated expertise includes:
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Rapid delivery of safety data & insights through FiH/SAD/MAD/DDI studies in our clinical pharmacology unit combined with our biometry consultancy
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Accelerate the PoC & efficacy data for your vaccine or anti-viral leveraging our globally recognised Human Challenge Trials using our world-class quarantine facility
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Expert-led design, rapid recruitment and advanced diagnostic capabilities delivered through our sites in UK and Germany to advance your Phase II/III studies
Challenge
Building on decades of unrivalled experience, hVIVO is a leading CRO with world-class expertise in delivering human challenge trials, challenge agent manufacture, a unique portfolio of infectious and respiratory disease models, and specialist drug development and clinical consultancy services.
Labs
hVIVO has a highly specialised infectious disease and immunology laboratory offering a suite of services to support pre-clinical and drug and vaccine discovery & development.
hVIVO have extended their storage offering to the biotech and pharmaceutical industries with locations in London and Cambridge, offering a dedicated GxP storage facility for biological and clinical materials in secure temperature-controlled conditions.
Consulting
hVIVO's integrated drug development consultancy supports life science innovators from early planning through clinical execution. With more than 25-years of experience, our team delivers a uniquely combined offering across CMC, non-clinical, clinical pharmacology, regulatory, data management and (translational) laboratory services, across the drug development and market authorisation spectrum.
