Toxicology & Safety Assessment

GLP-Compliant Preclinical Solutions

Our GLP-compliant toxicology platform delivers high-integrity, actionable safety data tailored to meet the rigorous demands of global regulatory submissions. By leveraging advanced analytical expertise, we provide the foundational evidence required to de-risk the journey into human trials.

GLP Toxicology & Safety Services

• General Toxicology (Single & Repeat Dose):
  Characterizing dose-limiting toxicities and determining No-Observed-Adverse-Effect Levels (NOAEL) to establish safety margins.
• Safety Pharmacology & Behavioral Observation:
  In vivo assessment of potential adverse effects on vital organ systems (Cardiovascular, Respiratory, and CNS), including standardized functional observational batteries (FOB).
• Genetic Toxicology:
  Standard battery of assays (Ames test, Chromosomal Aberration, Micronucleus) to evaluate potential mutagenicity and clastogenicity.
• Immunotoxicity & Local Tolerance:
  Evaluation of immune system modulation (cytokine profiling) and site-specific reactions (injection site, ocular, or dermal irritation).
• Dose-Exposure Response Studies:
  Integrated assessment of the relationship between administered dose levels and observed biological or toxicological responses to support clinical dose escalation.