Nonclinical & IND-Enabling Toxicology
Acute Toxicity Studies
The toxicology team has extensive experience across oral, dermal, and inhalation routes, as well as limit-dose and dose-escalation designs applicable to both pharmaceutical and agrochemical programs. Our well-documented study reports are structured to meet the expectations of international regulatory authorities.
Repeat-Dose Toxicity (Sub-acute, Sub-chronic, Chronic)
Conduct sub-acute (28-day), sub-chronic (90-day), and chronic (up to 12-month) studies in rodent and non-rodent species under full GLP compliance. Our experienced study directors and pathology teams ensure consistent histopathological evaluation, clinical pathology interpretation, and integrated data reporting. Study designs routinely incorporate satellite groups for toxicokinetic assessment.
DART (Developmental & Reproductive Toxicology)
Vanta reproductive toxicologists have experience designing tiered DART strategies that optimize resource allocation while satisfying the full requirements of global regulatory agencies. By integrating TK exposure data and historical control databases, we provide sponsors with contextually interpretable findings.
Fertility & Reproductive Toxicity
Vanta Bioscience conducts fertility studies with comprehensive endpoint evaluation — including sperm parameters, estrous cyclicity, fertility indices, and early embryonic survival — in GLP-compliant rodent models. Our team brings extensive experience in designing bridging and dose-range-finding studies that allow sponsors to enter pivotal fertility assessments with justified study designs.
Embryo-Fetal Development
Conducts EFD studies in rats and rabbits as standard. Visceral and skeletal examinations are performed by trained evaluators using standardized scoring systems, with rigorous internal quality checks to ensure inter-examiner consistency. Our EFD study reports include thorough integration of maternal and fetal findings with toxicokinetic exposure data.
Local Tolerance & Target Organ Toxicity
The pathology team works in close collaboration with study directors to design focused follow-up investigations that address specific regulatory questions or sponsor concerns arising from primary toxicology studies. This integrated approach resolves data gaps efficiently, avoiding the need for repeat studies.
Safety Pharmacology (CNS, Cardiovascular, Respiratory)
Vanta conducts core battery safety pharmacology assessments using validated, guideline-compliant methodologies, including the modified Irwin test for CNS evaluation, hERG channel inhibition and in-vivo QTc assessment for cardiovascular risk, and whole-body plethysmography for respiratory function. Our scientists design supplementary studies when core battery findings warrant further investigation.
Carcinogenicity & Long-Term Toxicity
Vanta supports sponsors through the complete carcinogenicity program lifecycle, from dose-range-finding and study design justification through to final report preparation and peer review. Our carcinogenicity studies are conducted under full GLP compliance, with peer-reviewed pathology review to ensure data defensibility. We have experience supporting submissions to the FDA, EMA, and regional health authorities.