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.
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, with certainty.
PK/PD studies delivered, with >97% on time delivery and extensive expertise across different therapeutic areas e.g. infectious disease, respiratory, immunology, cardiometabolic and oncology.
PK/PD analyses in the past three years, including ~125 full analyses post Data Base Lock.
Technical due diligence projects, supporting investors and acquirers across CMC, nonclinical, regulatory and quality domains.
Years of CMC expertise supporting drug substance/product development and GMP aligned manufacturing strategies.
Understanding and experience of EMA PRIME — a framework for supporting medicines addressing unmet medical needs through enhanced early dialogue and scientific advice.
Familiarity and experience with FDA Fast Track processes, supporting clients navigating expedited development routes for serious conditions with unmet therapeutics.
Extensive non-clinical leadership in toxicology, PK/TK, ADME and GLP aligned evaluations.
End to end CMC strategy, development and regulatory support from Target Product Plans (TPP), CDMO selection and management, early formulation and method development to GMP readiness and lifecycle management.
Comprehensive design, oversight and interpretation of toxicology, metabolism, PK/TK and GLP aligned nonclinical programs — enabling smooth transition into clinical phases.
Specialised early‑phase design and execution, including clinical pharmacology strategy, SAD/MAD study design, biomarker integration and translational modelling.
Expert clinical pharmacology and non-compartmental PK/PD analysis supporting Phase I–II decision making. Translational modelling to predict and define the safe starting dose for the first-in-human study.
High quality data oversight, biostatistics, RTSM and analysis supporting robust submissions across all phases.
Strategic regulatory guidance from IND/IMPD through MAA/BLA, including scientific advice, regulatory submissions and agency interactions (EU & FDA).
Full EU/UK legal representation, GDPR DPR/DPO services, and contract negotiation for sponsors conducting clinical trials.
The drug development lifecycle requires seamless interaction between scientific, operational and regulatory disciplines. hVIVO uniquely brings these components together under one integrated structure. By combining CMC, nonclinical, clinical, biometrics and regulatory expertise, we ensure continuity across development phases, reducing risk and enabling efficient, informed decision making.
Accelerate your drug development process with integrated scientific, regulatory and specialist expertise spanning early drug development (CMC, nonclinical and clinical) regulatory pathways, trial design, biometrics and assayrelated strategies. hVIVO Consultancy brings over 25 years of experience as an integrated drug development partner, supporting programmes from early concept through clinical execution.
Our multidisciplinary teams combine CMC, nonclinical, clinical pharmacology, biostatistics, data management, RTSM and regulatory affairs, ensuring cohesive program design and reduced risk across diverse therapeutic areas.
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