Facility
1State-of-the-Art Non-clinical and Standalone Clinical Bioanalytical Laboratories
Intox’s state-of-the-art preclinical research facilities, spanning over 50,000 square feet on a 5-acre campus in Pune, India, provide an ideal environment for comprehensive safety testing in rodent and non-rodent species, as well as bioanalysis to support non-clinical and clinical samples. We conduct over 1,200 safety studies annually, offering a full range of in vivo and in vitro GLP and non-GLP safety assessments for your drug substances, vaccine candidates, crop protection agents, industrial and speciality chemicals. Our facilities are equipped to support toxicology, safety pharmacology, genotoxicity, ecotoxicology, and complete analytical testing, all within the campus.
2Our Vivarium
Our facilities feature a state-of-the-art, two-floor vivarium with 50 rooms, tailored for various species to ensure animal welfare and research integrity. Environmental conditions are meticulously controlled and monitored through a centralized Environmental Monitoring System (EMS). One section of the vivarium is BSL-2 compliant, facilitating experiments with laboratory animals infected with agents related to human diseases, such as Mycobacterium, Streptococcus pneumoniae, and Salmonella choleraesuis.
The vivarium holds AAALAC accreditation and CCSEA approval.
3Laboratory Capabilities
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Analytical Chemistry: Equipped with advanced technologies, our lab provides precise chemical analyses essential for safety assessments.
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Clinical Chemistry: Utilizing state-of-the-art autoanalyzers, this lab offers comprehensive clinical chemistry evaluations for diverse studies.
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Bioanalytical: Capable of handling both small and large molecules, our bioanalytical lab supports extensive pharmacokinetic and toxicokinetic studies.
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Histopathology: Expertly staffed and fully equipped, this lab conducts detailed tissue analysis and pathological examinations.
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DART (Developmental and Reproductive Toxicology): Well-equipped laboratories to perform necropsies and fetal examinations.
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Ecotoxicology and Environmental Fate: Focused on assessing the environmental impact of chemicals, with robust capabilities for comprehensive ecotoxicological studies.
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Genotoxicity: Dedicated to evaluating genetic toxicity, employing a range of in vitro and in vivo assays to detect potential mutagenic effects.
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Inhalation Toxicology: This facility houses state-of-the art Nose only exposure system procured from CH Technologies, USA and TSE, Germany.
4Support Facilities
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Dry and Wet Archives: Secure and compliant storage solutions for all study-related documents and samples.
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Test Item Control Office: Centralized management of test items, ensuring proper storage, handling and documentation.
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Formulation Preparation Labs: Specialized labs for the precise preparation and management of test formulations.
- Test item store, Dose formulation preparation laboratory, Archives for documents, test item samples, and specimens.
5Accreditations and Compliance
We proudly hold accreditations from renowned bodies, showcasing our commitment to quality and compliance:
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OECD GLP certification: Recognized since 2007 for our adherence to Good Laboratory Practice standards.
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CDSCO: Approval for performing Standalone Regulatory Clinical Bioanalysis
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DSIR: Department of Scientific and Industrial Research accreditation, affirming our research capabilities.
We have a proven track record of successful data submission to global regulatory agencies, including US-FDA, US-EPA, Canada, European Union, UK, Brazil, Argentina, Japan, India, Australia, and China.