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Extended experience and understanding in toxicology is fundamental in ensuring that only the right tests are done in the correct order for each project.

We offer a full service of GLP compliant toxicological studies, as recommendend by the International Guidelines, to prepare your regulatory package.

In vivo toxicology has a central role in assessing the toxicology profile of, drug compounds, chemicals, novel food ingredients. In vivo toxicology can be done in both under accredited GLP (Good Laboratory Practice) settings as well as in early non-GLP settings. Non-GLP experiments are faster to conduct and with less expenditure, whilst regulatory toxicology and safety studies conducted under the GLP settings are needed in drug preclinical development, novel functional food and REACH chemical safety testing.

The goals of the non-clinical safety evaluation include:

  • characterization of toxic effects,
  • target organs,
  • dose dependence,
  • relationship to exposure,
  • potential reversibility.

The safety testing battery includes:

  • Single dose toxicity in rodents: We offer the single dose toxicity studies of fixed dose method, up-and-down procedure, toxic class method all according to the OECD guidelines.
  • Repeated dose toxicity in rodents: We offer the repeated dose toxicity studies of 7, 14, 28 and 90-days. Repeated dose studies are required for IND submission as well as in other regulated areas. We follow the OECD guidelines for conducting the repeated dose toxicity studies.
  • Embryo-foetal development in rats
  • Immunotoxicity
    • Hematology
    • Histopathology of lymphoid organs
    • NK cell activity
    • T-cell Dependent Antibody Response (Plaque assay)
    • Mixed lymphocyte reaction
    • Antigenicity (induction of humoral response)
  • Local tolerance
    • Mouse Local Lymph Node Assay
    • In vitro skin irritation and corrosion
  • Genotoxicity
    • Ames’ test (5 strains, 5 concentrations)
    • Mouse Lymphoma assay
    • In vivo micronucleous test
    • nscheduled DNA synthesis in vitro
    • HGPRT mutations in CHO cells
    • Chromosomal aberrations in vitro

All the in vivo studies are supported by toxicokinetics assessment.