GLP-compliant general toxicology solutions for expedited regulatory submissions
Aragen SAS is an experienced GLP-compliant non-clinical testing partner with over 28 years of history in conducting safety assessment studies. From designing a complete study program to running every single test, Intox can address all your requirements. Safety assessment studies are performed in compliance with global regulatory guidelines such as ICH, FDA, EMA, EU, OECD, OPPTS, JMAFF, and CIB. We work in a collaborative manner using our expertise to accomplish the safety assessment of your product.
Rely on our toxicology testing capabilities when it comes to single-dose and repeat-dose study designs (subacute/chronic). Our expert team enables the shortest turnaround time for study completion to expedite regulatory submissions. They can implement all dose routes including oral gavage, dietary, dermal, inhalation, and parenteral in all laboratory animals (rats, mice, rabbits, guinea pigs, hamsters, dogs, and NHP).
All animal experiments are reviewed and approved by the Institutional Animal Ethics Committee (IAEC). Our 50-room vivarium is approved by the CCSEA, Government of India and accredited by AAALAC. Historical data accumulated over the years is available on in-life parameters, clinical and anatomic pathology, genetic toxicology, and DART studies.
Acute Six Pack / Single-Dose Toxicity
- Acute oral toxicity in rat/mice
- Acute dermal toxicity in rat
- Acute inhalation toxicity in rat
- Eye irritation test in rabbit
- Skin irritation test in rabbit
- Skin sensitization test in guinea pig
- LLNA skin sensitization in mice
Repeat Dose & Chronic Studies in Rodents and Non-rodents
- Dose range finding studies - 7/10/14 days
- Repeat dose toxicology - 28 and 90 days
- Chronic toxicology studies - 180, 270 and 360 days
- Inhalation toxicology studies in rodents, nose-only exposure - Single dose, 7, 14, 28, 90 days duration
- Carcinogenicity and combined Carcinogenicity
- Carcinogenicity studies using Tg.rasH2
- Guidelines - OECD, ICH, WHO, OPPTS
