We expertly deliver end-to-end nonclinical development support, from designing tailored study programmes to managing CRO execution and preparing regulatory documentation.
Our team accelerates drug development by integrating seamlessly with your internal team of scientists to deliver safe, efficient next phase readiness.
Nonclinical testing is essential to assess safety and Pharmacokinetics and Toxicokinetic (PK/TK) characteristics across all drug development phases.
Gain experienced strategic guidance to design compliant, efficient nonclinical programmes without needing inhouse specialists.
Access integrated support to scale R&D operations, coordinate CRO activity and maintain regulatory alignment.
Strengthen internal teams with external multidisciplinary experts to streamline timelines, reduce workload and optimise overall development strategy.
Nonclinical development at hVIVO covers the full spectrum of safety, pharmacokinetic, toxicological and ADME assessments required to progress a medicinal product to clinical trials or registration.
The programme is tailored casebycase to reflect the scientific profile of each candidate rather than relying on generic regulatory templates.
Experts develop an optimal nonclinical plan based on the drug’s characteristics and intended clinical route.
We design and monitor all required toxicology, non-clinical PK/TK and metabolism studies.
The team selects the most suitable CRO, manages study design discussions, reviews and authorises protocols, and reviews study reports.
We act as your primary liaison with the CRO, ensuring continuity, efficiency and reduced operational burden.
Development of IBs, nonclinical summaries and overviews for global submissions and/or briefing books.
GLP accredited nonclinical PK/TK evaluations.
Our capabilities span comprehensive design, oversight, and evaluation across all nonclinical study types, ensuring every programme is scientifically robust, regulatoryready, and expertly managed end-to-end.
Design and monitoring of toxicology studies (acute, chronic, repeatdose, developmental- and reproductive toxicology, genetic toxicology and safety pharmacology with focus on use of non-animal alternative models where possible).
Pharmacokinetic and toxicokinetic (PK/TK) oversight across all nonclinical phases.
ADME studies supporting absorption, distribution, metabolism, and excretion evaluations.
Full CRO management, including study design discussions, protocol review, and study report review.
Single point-of-contact oversight, acting as the primary liaison with CROs to streamline communication.
Preparation of regulatory documentation, including Investigator Brochures, nonclinical summaries, and overviews for submissions and briefing books.
GLP-accredited PK/TK evaluations across all nonclinical study types.
It assesses safety, PK/TK and potential red flags before clinical trials, maximising the probability of success of your drug-development pathway.
No. Strategies are created case-by-case depending on the drug’s characteristics and therapeutic goals.
Yes. hVIVO selects CROs, manages communications, reviews protocols and reports, and acts as your main operational contact.
Yes. The team is accredited for PK/TK evaluations in accordance with GLP.
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