Preclinical / Non-clinical In Vivo Toxicology
Agilex Biolabs offers a range of toxicology services to support non-clinical through to early/late-phase clinical programs through our state-of-the-art, custom-built GLP facility located in Brisbane, Australia. These services include exploratory (non-GLP) toxicology and pharmacokinetics studies, and GLP toxicology services. We have extensive experience working with a wide range of therapeutic modalities and routes of administration.
TOXICOLOGY
Our scientific experience
Agilex is Australia’s largest and most experienced GLP toxicology lab, combining onshore capabilities and international CRO partnerships to help clients navigate their IND-enabling process. Our team has decades of experience in supporting GLP studies across a range of drug modalities (small molecule, biologics, vaccines, cell and gene therapies) and remains the only GLP lab in Australia to support GLP toxicology studies using immunocompromised animals. If you’re planning your Phase 1 in Australia, speak with our US Board Certified Toxicologists about getting a head start on your preclinical safety data.
Agilex Biolabs’ team have extensive experience in successfully designing and executing regulatory toxicology studies for submission to various international regulatory bodies including FDA and EMA.
Our Partnerships
Agilex has established a partnership throughout USA and APAC, making it easy for our clients to not have to choose between price, quality, and timelines. With this collaboration, our sponsors can fulfill the global requirement for two species for standard toxicology testing as stated in the international conference for hominization guidelines.
In-house
- All in-vivo activities
- Clinical Pathology
- Necropsy
- Reporting
- Dose Solution Analysis
- Bioanalysis
- Quality Assurance
Outsourced Services
- Histopathology
- Genetox
- hERG / Ames
- Safety Pharmacology
- Second species studies
Drug sponsors from all over the globe are coming to Australia for their first-in-human (FIH) clinical trials to take advantage of the most efficient regulatory pathway in the world. Increased access to critical nonclinical testing in Australia allows additional efficiencies, as studies performed by reputable organizations in Australia can enable more streamlined regulatory approval for clinical trial startup.
Additionally, eligible companies can receive a 43.5% tax rebate on clinical spend and all R&D work placed in Australia preceding an Australia clinical trial – including pharmacokinetics (PK), toxicology testing, and supportive bioanalysis.
Agilex’s growing team of qualified study directors and technicians use Provantis data management software system for study management and data collection, compliant with FDA 21 CFR Part 11. The Provantis software is used for recording body weights, clinical observations, dose administration, food and water consumption, as well as other user specified parametres. Interim and final reporting is facilitated by centralized data management, allowing rapid delivery of written reports to clients.
If you are interested in learning more about Agilex’s nonclinical study offerings or would like to get your study in the queue, use our Contact Us form and a representative will be in touch with you shortly.
OUR TEAM
Toxicology Team
Agilex Biolabs is powered by a multidisciplinary team of over 150 highly trained professionals—scientists, analysts, study directors, and regulatory experts—committed to scientific excellence and client success. Our leadership combines global industry experience with a passion for innovation and quality.
While headquartered in Australia, Agilex Biolabs supports studies across North America, Europe, and Asia-Pacific. Our reputation for proactive communication, flexible service models, and fast turnaround makes us trusted partners for sponsors pursuing novel therapeutics and biosimilars alike.
THE LATEST
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World class technology
Over 28 years of experience in developing and validating robust compliant immunoassay, immunogenicity, and cell-based assays to support nonclinical and clinical programs.
Experts in overcoming bioanalytical challenges from new chemical and biological entities.
Agilex offers a wide range of kit productions and logistics services to explore
Supporting non-clinical through to early/late-phase clinical programs through our state-of-the-art, custom-built GLP facilities.
Determine key insights into a therapeutic’s efficacy, safety profile, and mechanism of action.
