We expertly deliver end-to-end non-clinical 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.
Non-clinical testing is essential to assess safety and Pharmacokinetics and Toxicokinetic (PK/TK) characteristics across all drug development phases.
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High quality non-clinical design helps identify “knockout” criteria early, increasing downstream clinical success.
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hVIVO manage and monitor all toxicology, PK/TK and metabolism (ADME) studies end-to-end.
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Accredited to perform PK/TK evaluations under GLP compliance.
What This Service Is
Non-clinical 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 case by case to reflect the scientific profile of each candidate rather than relying on generic regulatory templates.
Working with hVIVO
Programme Design
Experts develop an optimal nonclinical plan based on the drug’s characteristics and intended clinical route.
Study Oversight
We design and monitor all required toxicology, non-clinical PK/TK and metabolism studies.
CRO Management
The team selects the most suitable CRO, manages study design discussions, reviews and authorises protocols, and reviews study reports.
Single Point of Contact
We act as your primary liaison with the CRO, ensuring continuity, efficiency and reduced operational burden.
Regulatory Documentation
Development of IBs, nonclinical summaries and overviews for global submissions and/or briefing books.
PK/TK Evaluation
GLP accredited nonclinical PK/TK evaluations.
Our Experience
- End-to-end nonclinical leadership, guiding programmes from lead candidate selection to market.
- Strategic programme design, offering case-by-case tailored planning rather than generic regulatory templates.
- Ability to integrate seamlessly with internal R&D, acting like an extension of your team and enabling accelerated development.
- Strong operational governance, ensuring milestones, timelines, and budgets are met with scientific rigour.
- Reduced operational burden, thanks to hVIVO taking full responsibility for CRO coordination and communication.