Pioneering Bio Science Research · GLP-compliant preclinical CRO
Advancing Human Health Through Molecular Innovation
Vanta Bioscience combines science, compliance, and collaboration to accelerate innovations from concept to commercialization.
Years Test Facility
Studies Conducted
Man-years Experience
Data Integrity Issues
Scientific Services
Discovery, Biology & Early
Pharmacology
In-vitro Pharmacology & Screening Assays-
Vanta’s assay development team has over a decade of experience designing and executing primary and counter-screening panels across diverse target classes. Our robust quality systems and documented assay validation support confident go/no-go decisions at the earliest stages of development.
Cell-Based Functional Assays-
Cell-Based Functional Assays-Vanta Vanta Bioscience operates with well-characterized cell lines and primary cell systems, applying rigorous assay qualification to ensure data reliability across experimental runs. Our experience spans small molecules, biologics, and combination products, allowing sponsors to obtain actionable functional data aligned with early regulatory expectations.
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.
Genetic Toxicology & Impurity Qualification
Vanta has conducted the Ames test across a wide range of substance classes — including drug candidates, impurities, metabolites, and formulated agrochemical products — with extensive experience addressing solubility and cytotoxicity challenges. Our validated in-house protocols, historical solvent control databases, and experienced GLP study directors ensure reliable, interpretable results.
Agrochemical Toxicology & Human Risk Assessment
Mammalian Toxicology for Agrochemicals-
Vanta has extensive experience designing and conducting the full mammalian toxicology package required for active substance and formulation product registration, including guideline studies in rats, mice, and rabbits. Our GLP-certified facilities and experienced study directors ensure the documentation quality required for multi-jurisdictional regulatory submissions.
Ecotoxicology & Environmental Safety
Fish-
Conducts fish toxicity studies in GLP-compliant controlled aquatic systems using standard test species, including Oncorhynchus mykiss, Danio rerio, and Oryzias latipes, with rigorous water quality monitoring and analytical verification of test substance concentrations. Our experienced aquatic toxicology team addresses challenges posed by poorly soluble and volatile test substances.
INDUSTRIES
Delivering trusted, GLP-compliant research and safety solutions for industries worldwide
Pharmaceuticals & Biopharmaceuticals.
Vanta supports pharmaceutical and biopharmaceutical sponsors across the full preclinical continuum ….
Medical Devices & Combination Products
Conducts the full suite of ISO 10993-compliant biocompatibility studies — including cytotoxicity, sensitization…
Agrochemicals & Crop Protection
Supports agrochemical, crop protection, biopesticide, and plant protection product sponsors across the full….
Veterinary & Environmental Chemicals
Conducts the toxicological, residue, and environmental safety studies required to support veterinary medicinal product….
Industrial & Specialty Chemicals
Supports chemical manufacturers and importers in meeting REACH and TSCA standard information requirements….
Food, Nutraceuticals & Feed
Generates safety data for novel food ingredients, nutraceuticals, dietary supplements, and feed additives aligned….
Cosmetics & Personal Care
Vanta supports cosmetic and personal care manufacturers in substantiating ingredient and finished product safety…
Department & Facilities
Analytical Chemistry
This department handles method development, validation, and routine analysis for study types including toxicokinetics, pharmacokinetics, residue analysis, and stability testing. It is equipped with HPLC, LC-MS/MS, UV-Vis spectroscopy, and other validated instruments for complex biological and environmental samples. All methods are validated per ICH and OECD guidelines before use, with GLP-compliant data capture throughout. The team ensures concentration data underpinning exposure assessments are scientifically sound and regulatorily acceptable. With over a decade of experience, they are well-equipped for challenges like low-abundance analytes, complex matrices, and multi-residue panels.
Ecotoxicology
The Ecotoxicology department conducts regulatory studies assessing the environmental hazard and risk of chemicals, agrochemicals, and pharmaceuticals. Capabilities include aquatic toxicity testing in fish, invertebrates, and algae, and terrestrial assessments in earthworms, birds, and plants per OECD guidelines. Environmental conditions are closely controlled, and exposure concentrations are analytically verified to ensure valid dose-response data. The team has hands-on experience with ecotoxicology-specific challenges like organism acclimatization, solubility-limited exposures, and ecological endpoint interpretation. Study designs are aligned with sponsors before initiation to meet current regulatory expectations and minimize the risk of protocol deviations.
Pathology (including Clinical Chemistry)
The Pathology department provides both in-life and post-mortem assessments that form the core evidence base for toxicological evaluation. Clinical pathology covers hematology, coagulation, serum biochemistry, and urinalysis using validated automated platforms with strong attention to sample quality. Gross pathology and histopathological examinations are conducted under standardized protocols by experienced veterinary pathologists. Findings are integrated across clinical, organ weight, and histopathological data to support NOAEL determinations and risk characterization. The department’s experience with repeat-dose, carcinogenicity, and reproductive toxicology studies meets the rigorous standards expected under OECD and ICH guidelines.
Genetic Toxicology
This department performs a core genotoxicity battery per ICH S2(R1) and OECD guidelines. Key assays include the Ames test, mammalian cell genotoxicity assays, and rodent bone marrow and peripheral blood micronucleus studies, all conducted under GLP conditions. Validated test systems with characterized positive and negative control data ensure study reliability. Particular attention is given to metabolic activation, cytotoxicity, and dose selection — areas commonly flagged in regulatory reviews. The team has broad experience across pharmaceuticals, industrial chemicals, agrochemicals, and medical device extracts, including interpretation of ambiguous results.
Animal Facility
The Animal Facility supports in-life study phases with dedicated housing for rats, mice, and other rodents under controlled temperature, humidity, and light cycles, in compliance with animal welfare and GLP requirements. Separate quarantine, acclimatization, and study rooms prevent cross-contamination and protect animal welfare. Feed, bedding, and water are sourced from qualified suppliers and monitored analytically to exclude confounding contaminants. Clinical observations are recorded at defined intervals by trained personnel using standardized scoring criteria. The facility is capacity-managed to support concurrent study groups while maintaining animal welfare and study integrity even during peak utilization.
Quality Assurance
At Vanta Bioscience, the Quality Assurance Unit serves as the backbone of our GLP compliance framework, providing independent oversight of all study conduct, data integrity, and regulatory documentation. Our QA team performs systematic audits of facilities, equipment, SOPs, and in-life study phases to ensure every program meets the standards required by global regulatory authorities, including OECD, US EPA, and ICH guidelines. Study sponsors can be confident that each deliverable from Vanta has been independently reviewed and verified before release.
Engineering & Maintenance
This department ensures the operational continuity of all facility infrastructure critical to GLP study execution, including HVAC, environmental monitoring, utilities, and laboratory instrumentation. Preventive maintenance is documented per manufacturer specifications and site SOPs, with all activities logged in equipment records that form part of the GLP audit trail. A structured calibration program ensures all measurement instruments are traceable to national or international standards and recalibrated on schedule. The team also manages facility qualification activities and addresses equipment discrepancies proactively before they affect studies. This approach minimizes the risk of environmental excursions, equipment failures, or calibration lapses that could compromise data acceptability in regulatory submissions.
Information Technology (including Document Control, Test Item Control, Archives)
The IT function maintains the data infrastructure, document management systems, and electronic controls that underpin GLP compliance across Vanta. Validated LIMS and electronic data capture systems meet regulatory data integrity requirements, including audit trails, access controls, contemporaneous recording, and backup protocols. Document Control governs the full lifecycle of SOPs, protocols, amendments, and reports, ensuring only approved, current versions are in active use. Test Item Control manages receipt, storage, dispensing, and disposition of all test and reference items with full chain-of-custody documentation. The Archives function provides secure, long-term storage and retrieval of study records for audits and regulatory inspections, collectively forming the compliance backbone that supports scientific data across all departments.
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