Toxicological Risk Assessment - Overview
Toxicological Risk Assessment (TRA) is a comprehensive safety-evaluation report for a specific ingredient or contaminant in the product. TRA is a detailed scientific assessment report prepared by an expert toxicologist based on sound scientific knowledge on the available information/data pertaining to the specific ingredient within the context of nature of the product, its dosage/concentration, and exposure scenario.
Freyr toxicologists, with their vast experience in toxicological risk assessment of pharmaceuticals, cosmetics, medical devices, food, and consumer products, have delivered numerous high quality TRA reports and non-clinical study report templates to many clients across the globe.
Toxicological Risk Assessment - Expertise
Pharmaceuticals
- Safety evaluation and assessment of pharmaceutical excipients per the intended formulation and clinical usage.
- Clinical exposure assessment, qualification, and Regulatory support for the DP/DS impurities.
- Integrated safety evaluation and assessment of new drugs as part of drug discovery and development.
Medical Device
- Biocompatibility safety assessment of medical devices per their intended surface contact and duration, based on ISO-10993.
- Safety evaluation and Regulatory support for extractables and leachables.
Cosmetics
- Human risk assessment and individual hazard assessment of flavors and fragrances.
- Safety assessment of cosmetics and their individual ingredients.
Consumer Products
- Toxicological risk assessment and exposures calculation for various consumer products viz, e-cigarettes, single, and multi-component ingredients, or mixtures.
Food
- Assessing the hazards of natural compounds associated with food contamination.
- Derivation of Health Criteria Values (HCVs) for substances present in food.
- Recommending a Tolerable Daily Intake (TDI) for a contaminating pesticide.
- Toxicological risk assessment of food-contact material migrants and derivation of oral TDIs.
General Chemicals
- Complete safety reports for the chemicals per various regulations like the REACH.
- The Globally Harmonized System’s (GHS’s) classification services.
- Safety Data Sheet (SDS)/Material Safety Data Sheet (MSDS) services.
