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Facility and Compliance

Facility

  • Over 25 years of expertise in conducting safety assessment studies for pharmaceuticals, bio-pharmaceuticals, medical devices, agrochemicals, industrial chemicals, neutraceuticals /dietary supplements, cosmetics and others
  • 15,000+ GLP studies conducted
  • 45,000 sq.ft. OECD-GLP certified laboratory and Animal Research Facility
  • Team of ~ 120 Experienced & Qualified personnel with diverse skill sets including board-certified toxicologists (DABTs), pathologists (ACVP and DIBTP), study directors, study personnel, veterinarians, analysts and QAU
  • Track record of successful data submission to global regulatory agencies including US-FDA, US-EPA, Canada, European Union, UK, Brazil, Argentina, Japan, India, Australia & China

Vivarium

Intox offers state-of-the-art, ABSL2 compliant vivarium with multispecies capacity, enabling you to start up to several hundred animals at a given time.

  • AAALAC accredited and CCSEA compliant
  • 25,000 square feet vivarium
  • 24/7 environmental and security monitoring
  • >12-15 air changes per hour, controlled environmental conditions
  • Option for individual, group and/or social housing
  • Enrichment for Animal Welfare
  • Option of Individually ventilated cage housing for rodents
  • Housing of SPF rodents from Charles River Inc., Taconic & Jackson Laboratories

Animal Ethics & Welfare (IAEC)

  • 24-hours access to on-site attending veterinarians
  • Approval of experimental protocols by Institutional Animal Ethics Committee
  • Adherence to national animal welfare guidelines (CCSEA) and global such as FELASA

Institutional Biosafety Committee (IBSC)

  • DBT-registered IBSC to review, edit and approve all studies involving biological materials
  • These approvals assure proper handling and disposal precautions recommended by Sponsors and Regulatory agencies

Route of Administration

  • Oral through gavage, dietary or drinking water
  • Dermal
  • Implant
  • Inhalation
  • Intracutaneous
  • Intramuscular
  • Intranasal 
  • Intraperitoneal
  • Intrathecal
  • Intratracheal
  • Intravenous- Bolus, Infusion- Tail vein /Ear vein
  • Intraintestinal
  • Intraarterial
  • Rectal
  • Subcutaneous
  • Vaginal

Test Species

  • Rodent/Small animal
    • Rat- Wistar, Sprague Dawley
    • Mouse- Swill albino, Balb C, C57BL6J, Tg.rasH2
    • Rabbit- New Zeeland white
    • Guinea Pig- Duncan Hartley
    • Hamster- Syrian Golden
  • Non-rodent \ Large animals (with Partner CRO)
    • Dog- Beagle
    • NHP
    • Mini-pig
    • Goat
  • Other
    • Chicken
    • Pigeon
    • Quail
    • Fish
    • Earthworm
    • Honey bee

Laboratory and Other Support Areas

  • Laboratories
    • Necropsy, Histopathology
    • Reproductive Toxicology
    • Clinical Pathology
    • Bioanalytical / Bioassay
    • Chemistry / Analytical Chemistry
    • in-vitro Toxicity / Mutagenicity
    • Ecotoxicology
    • Inhalation Toxicology
  • Support Areas
    • Test item store
    • Dose formulation preparation laboratory
    • Archives for document, test item samples and specimen

Provantis® Software Solution
Provantis® is a modern, fully integrated Windows-based system being used at Intox for real-time data capture, computation and reporting for all toxicology studies.

SEND Capabilities
Intox provides data in SEND format for submission of preclinical data to regulatory agencies.

Bioanalysis
Intox provides integrated as well as standalone bioanalytical services for small and large molecules. These services include Clinical Bioanalysis from a dedicated laboratory.

Pathology Services
Intox was founded by eminent veterinary pathologists and understands its utmost importance.

  • Clinical Pathology
    Labs are well equipped with autoanalyzer’s and trained team of technicians.

    • Haematology analysis – Fully automated, Five Part, veterinary specific
    • Biochemistry analysis – Fully automated
    • Coagulation parameter
    • Urine analysis
    • BALF analysis
    • Hormone analysis – Thyroid, Reproductive
    • Sperm assessment analysis
    • Quantitative Bone Marrow Evaluation
  • Histopathology
    Intox pathology team has board certified pathologists (ACVP and DIBTP) and team of technicians. Labs are equipped to perform necropsies, histopathology evaluation and peer-reivew. In addition to internal expertise, Intox has a network of peer-review pathologists.

    • Quality control: 100% slide check
    • Necropsy procedures –General, DART, and Inhalation studies
    • Histology procedures & histopathology evaluation
    • Immunohistochemistry (IHC)
    • Histomorphometry
    • Imaging analysis: Digital pathology

Regulatory Guidelines Compliance