Acute toxicity studies:
- Single and repeat dose studies up to 14-days duration according to OECD Test Guidelines or custom study design
- Custom design for dose range finding and maximum tolerated dose studies
- Dermal toxicity
- Skin irritation/corrosion test in rabbits
- Local lymph node skin sensitisation test in mice
- 28-day and 13-week repeat dose toxicity studies
- Repeat dose studies according to OECD Test Guidelines
Chronic toxicity studies
- 6-, 9- or 12-month duration
- Skin sensitisation and skin irritation studies
- Clinical pathology including in-house haematology, clinical biochemistry, histopathology analyses
- Bioanalytical support for toxicokinetic studies
- Consulting Services
Administration routes available include:
- Intravenous injection
- Urinary Bladde
The above studies can be performed in a range of species. vivoPharm Global Pty Ltd has exceptional expertise in rodent toxicology studies. Dog and non-human primate studies are performed with vivoPharm Global Pty Ltd’s GLP compliant partners.
Services are performed in compliance with regulatory authority test guidelines and are fully GLP compliant.
Non-GLP services are also available on request.
vivoPharm Global Pty Ltd’s team has extensive experience designing and executing regulatory toxicology studies for submission to various international regulatory bodies including FDA, TGA and EMA.
Sponsors from overseas coming to Australia for their IND related research programs to take advantage of the most efficient regulatory pathway in the world. Superior GLP-compliant critical nonclinical testing in Australia allows for additional efficiencies, as studies performed by reputable organizations in Australia, such as vivoPharm, can enable more streamlined regulatory approval for clinical trials.
Additionally, eligible companies can receive up to 43.5% tax rebate on all R&D work contracted in Australia– including all vivoPharm services.
vivoPharm Global Pty Ltd with partners supports overseas customers to setup their presents in Australia to become eligible to the Tax R&D program.
vivoPharm Global Pty Ltd’s utelises Provantis a LIMS software from Instem system for study management and data collection, compliant with FDA 21 CFR Part 11. Provantis is used all in vivoand ex-vivo generated data. In addition vivoPharm Global Pty Ltd stores data in state-of the Art Document management systems and three levels of data redundancy.