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.
- Safety evaluation and assessment of pharmaceutical excipients as per 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.
- Biocompatibility safety assessment of medical devices as per their intended surface contact and duration, based on ISO-10993.
- Safety evaluation and Regulatory support for extractables and leachables.
- Human risk assessment and individual hazard assessment of flavours and fragrances.
- Safety assessment of cosmetics and its individual ingredients.
- Toxicological risk assessment and exposures calculation for various consumer products viz e-cigarettes, single, and multi-component ingredients, or mixtures.
- Toxicological risk assessment of food-contact material migrants and derivation of oral TDIs.
- 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.
- Complete safety reports for the chemicals as per various regulations like the REACH.
- GHS classification services.
- SDS/MSDS services.