Delivering trusted, GLP-compliant research and safety solutions for industries worldwide
Pharmaceuticals & Biopharmaceuticals
Vanta supports pharmaceutical and biopharmaceutical sponsors across the full preclinical continuum — from small molecule impurity profiling and GLP-compliant genotoxicity studies under ICH Q3A/Q3B, to species-justified biologics toxicology programs aligned with ICH S6(R1) and regional biosimilarity guidance. For advanced modalities such as gene and cell therapies, the organization delivers biodistribution studies, integration site analyses, and genotoxicity risk assessments responsive to FDA, EMA CAT, and ICH S12 frameworks. ADC programs benefit from repeat-dose toxicology with toxicokinetic profiling of both intact conjugate and free payload, alongside tissue cross-reactivity and cytotoxic warhead genotoxicity evaluations per ICH S9. Vaccine development is supported through immunogenicity studies, local tolerance assessments, and systemic toxicology evaluations for novel adjuvants, delivery platforms, and nucleic acid-based constructs across both human and veterinary programs.
Medical Devices & Combination Products
Conducts the full suite of ISO 10993-compliant biocompatibility studies — including cytotoxicity, sensitization, irritation, acute systemic toxicity, and genotoxicity — as well as extractable and leachable assessments linking chemical characterization to toxicological risk thresholds. For combination products that integrate a device with a drug or biologic component, the organization applies cross-disciplinary scientific capabilities to build cohesive preclinical strategies that satisfy both device biocompatibility expectations under FDA, EU MDR, and CDSCO frameworks and pharmaceutical toxicology requirements within a single regulatory submission.
Agrochemicals & Crop Protection
Supports agrochemical, crop protection, biopesticide, and plant protection product sponsors across the full regulatory data set required by US EPA, EFSA, and national authorities under EU Regulation 1107/2009. Programs span acute through chronic mammalian toxicology, genotoxicity batteries, reproductive and neurotoxicity studies, ecotoxicology in terrestrial and aquatic species, and environmental fate assessments — all executed under OECD Test Guidelines and GLP certification. For biopesticides and biostimulants, safety frameworks are adapted to the biological nature of the active, including infectivity, pathogenicity, and environmental persistence evaluations proportionate to actual risk profiles. The organization’s familiarity with tiered data requirements across synthetic and biological PPPs enables sponsors to build cost-efficient, multi-jurisdictional dossiers with well-justified study selections and minimal redundancy.
Veterinary & Environmental Chemicals
Conducts the toxicological, residue, and environmental safety studies required to support veterinary medicinal product registrations under VICH, EMA CVMP, and FDA CVM frameworks, including target animal tolerance studies, consumer safety evaluations aligned with Codex MRL standards, and environmental risk assessments for persistent compounds. For industrial and environmental chemicals subject to REACH or EPA TSCA evaluation, the organization delivers OECD-guideline-compliant mammalian hazard data with GLP certification, applying read-across and QSAR-supported strategies to rationalize study burden across diverse chemical structures, complex mixtures, and substances with inhalation or dermal occupational exposure relevance.
Industrial & Specialty Chemicals
Supports chemical manufacturers and importers in meeting REACH and TSCA standard information requirements, conducting acute and repeated-dose toxicology, genotoxicity, reproductive toxicity, and ecotoxicology studies scaled to production volume and intended use. GLP-certified data is generated in compliance with ECHA dossier standards and EPA pre-manufacture notification requirements, with read-across and QSAR strategies applied where appropriate to minimize unnecessary testing. The organization’s experience with reactive intermediates, functional additives, and substances with complex physicochemical behavior ensures that study designs accurately reflect real-world exposure conditions.
Food, Nutraceuticals & Feed
Generates safety data for novel food ingredients, nutraceuticals, dietary supplements, and feed additives aligned with EFSA, FDA, FSANZ, and FSSAI regulatory expectations, including tiered genotoxicity studies, sub-chronic and chronic feeding studies, and reproductive toxicity assessments designed to establish acceptable daily intakes. The organization supports GRAS determinations, EU novel food applications, and EFSA FEEDAP evaluations with toxicological summaries and feeding study designs that reflect realistic dietary exposure scenarios. Scientific familiarity with botanicals, fermentation-derived ingredients, and bioactive compounds with endocrine or microbiome-relevant activity enables sponsors to present credible, well-structured safety arguments to specialized regulatory reviewers.
Cosmetics & Personal Care
Vanta supports cosmetic and personal care manufacturers in substantiating ingredient and finished product safety through in vitro and in vivo studies aligned with the SCCS Notes of Guidance, EU Cosmetics Regulation 1223/2009, US MoCRA requirements, and CDSCO Cosmetics Rules. The safety portfolio covers skin and eye irritation, validated non-animal sensitization assays (KeratinoSens, h-CLAT, DPRA per OECD 442C/D/E), phototoxicity, mutagenicity, and repeated-dose or reproductive toxicity endpoints for systemically absorbed actives informing margin of safety calculations. Practical experience with leave-on formulations, preservative systems with sensitization liability, and rinse-off products with aquatic relevance enables an exposure-driven safety approach that brings compliant products to market with confidence.