At Aragen, we are committed to being a ‘one stop partner’ for our clients’ IND filing needs. GLP safety assessment is an important part of the drug discovery process, offering critical data for timely pipeline decisions for our clients. Aragen offers Safety Assessment and Toxicology Services from its AAALAC-accredited and OECD certified research facility in Pune, India.

Along with existing discovery phase pharmacokinetic and efficacy data, Aragen’s DABT board-certified toxicologists utilize data from non-GLP acute and dose range finding studies to optimize the dosing regimen for GLP repeat-dose toxicology and safety studies. These non-GLP staging studies are of the utmost importance to identify the toxic threshold of a test article leading into designing pivotal GLP studies.

A bioanalytical method is the basis by which any correlation of adverse effects to test articles can be assessed. Our skilled bioanalytical team will develop, optimize and validate all bioanalytical methods for each species and matrices from discovery through development whether an industrial chemical, a drug, a vaccine or a plant-extract based biostimulant.

Services for Pharmaceutical and Biotechnology Industries

  • Analytical/Bioanalytical Method Development and Validation
  • Pharmacokinetics/Toxicokinetics
  • nonGLP Dose Range Finding Studies
  • IND-Enabling GLP Toxicology & Safety 
  • NDA/BLA-Enabling GLP Toxicology & Safety
  • Nonclinical and Clinical Bioanalysis

Services for Chemical and Agrochemical Industries

  • Analytical/Bioanalytical Method Development and Validation
  • Pharmacokinetics/Toxicokinetics
  • Product Composition and Characterization
  • Aquatic and Terrestrial Ecotoxicology
  • Environmental Fate and Behavior 
  • Mammalian and Genetic Toxicology
  • Residue and Metabolism Testing

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