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Non-Clinical Safety Assesment, IND & NDA Enabling Studies With Bioanalysis (Non-Clinical & Clinical)

Intox is an OECD GLP-certified preclinical safety assessment service provider with 25+ years of expertise in conducting safety assessment studies for small and large molecules. The state-of-the-art facility is spread across 45,000 sq ft in Pune, India. Our scientific team of experts includes board-certified toxicologists (DABTs), pathologists (ACVP and DIBTP), study directors, study personnel, veterinarians, analysts, and QA personnels.

Over the years, we have conducted more than 16,000 GLP studies for a wide range of industries including pharmaceutical, bio-pharmaceutical, medical device, agrochemical, industrial chemical, nutraceuticals/dietary supplements, cosmetics and others.

Snap Shot

  • Subsidiary of Aragen Life Sciences
  • Track record of successful data submissions to regulatory agencies of US-FDA, US-EPA, Canada, European Union, UK, Brazil, Argentina, Japan, India, Australia and China
  • State-of-the-art, ABSL2-compliant vivarium with multispecies capacity, enabling you to start up to
    several hundred animal studies at a given time
  • AAALAC accredited and CCSEA compliant facilities
  • 25,000 square feet vivarium
  • SPF rodents from Charles River Inc., Taconic and Jackson Laboratories
  • 25 Years of expertise in GLP safety assessment, IND enabling studies, carcinogenicity & clinical

Nonclinical Safety Assessment of New Chemical Entities (NCE)
IND in 9 Months

Timeline can be optimised upon understanding of molecule and regulatory pathway

Regulatory Compliances

Test systems and routes of exposure
Test Species
  • Rats, mice, guinea pigs, rabbits, hamsters
  • Dogs, Minipigs and Non-Human Primates,
    available through our collaborating test facilities
Routes of Exposure
  • Oral (gavage & dietary), dermal, inhalation, parenteral (IV/SC/IM/ID)
  • Other – Intranasal, ocular, intra-vitreal, otic,intra-articular
  • Implantation
Bioanalytical / Bioassay Services:
  • Single/Repeated Dose Pharmacokinetics
  • Toxicokinetics
  • Immunogenicity (ADA)
  • Immunotoxicology
  • Biomarkers
  • Biodistribution/Persistence
Safety Pharmacology:
  • Single/Repeated Dose Pharmacokinetics
  • hERG Assay
  • hERG Assay
  • CNS- Modified Irwin Test
  • Biomarkers
  • RESP-Whole Body Plethysmography
Studies offered
Acute Toxicity
  • Acute oral, dermal, and inhalation toxicity
Subacute/ Subchronic / Chronic Toxicity / Carcinogenicity
  • 7-day (DRF), 14-day, 28-day, 90-day, 180-day
    and 12-month repeat dose studies
  • 18-month/24-month carcinogenicity bioassays
  • Tg.rasH2 6 months Carcinogenicyty.
  • Implantation studies on medical devices
Reproductive Toxicity
  • Segment I
  • Segment II
  • Segment III
Genotoxicity
  • In-vitro / in-vivo studies
  • Gene mutation – Bacterial (Ames test); mammalian cells
  • Chromosome Aberration; Micronucleus Test

Bioanalytical Services

Services:
Toxicokinetics / Pharmacokinetics
  • Small and Large Molecules
  • Rodents, Dogs, Rabbits & NHPs
Immunogenicity (Anti-drug Antibodies), Biodistribution,
Bioassay and Biomarker analysis
  • Biosimilars
  • Vaccines
  • Novel biologics
Method Development / Validation /Sample Analysis
  • Sblood, urine and other matrices
Toxicokinetic /Pharmacokinetic analysis
  • WinNonlin soware for TK analysis and reporting

Track record of evaluation of biosimilars vaccines and NCEs

Bio-Pharmaceuticals:
  • Insulins / rH-Insulin Analogs
  • Interferon
  • Filgrastim#
  • PEG-Filgrastim#
  • Interleukin-11
  • Teriparatide (PTH)
  • Liraglutide
  • PEG-Erythropoietin
  • Erythropoietin
  • Asparginase
  • PEG- Asparginase
  • Anakinra
Antibodies
  • Trastuzumab
  • Rituximab
  • Ranibizumab
  • Adalimumab
  • Omalizumab
  • Bevacizumab
  • Cetuximab
  • Denosumab
  • Golimumab
  • Ustekinumab
  • Pertuzumab
  • Aflibercept
Vaccines ( Recombinant & Non-Recombinant)
  • Influenza H1N1 Inactivated Vaccine
  • Influenza H1N1 Live attenuated Vaccine
  • Meningitis – A Conjugate Vaccine
  • Meningococcal polysaccharide vaccine
  • Rabies Vaccine Inactivated
  • JAIVAC-1 (Plasmodium falciparum PfF2+PIMSPI19 Formulated in Montanide ISA720).
  • Malaria Vaccine
  • 10-valent Pneumococcal Polysaccharide Conjugate Vaccine
  • Recombinant Epsilon Toxoid Vaccine (Veterinary Product)
  • Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccine
  • SARS CoV-2 VLP, protein, antiserum, Vector, mRNA and DNA vaccines
New Chemical Entitles
  • Simultaneous methods for prodrugs and its two active metabolites
  • 6-substituted-3h-1,3-benzothiazole
  • Bisbenzimidazole HCL
  • Gemcitabine
  • 6-Substituted dimethyl pyridine 3 sulfonamide