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 all available information/data pertaining to the specific ingredient within the context of nature of 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.
Freyr Expertise
Pharmaceuticals
- 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
Medical Device
- Biocompatibility safety assessment of medical devices as per its intended surface contact and duration as per ISO-10993
- Safety evaluation and Regulatory support for extractables and leachables
Cosmetics
- Human risk assessment and individual hazard assessment of flavours and fragrances
- Safety assessment of cosmetics and its 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
- Toxicological risk assessment of food-contact material migrants and derivation of oral TDIs
- Assessing the hazards of natural compounds associated with food contamination
- Derivation Health Criteria Values (HCVs) for substances present in food
- Recommending a Tolerable Daily Intake (TDI) for a contaminating pesticide
General Chemicals
- Complete safety reports for the chemicals as per various regulations like REACH
- GHS classification services
- SDS/MSDS Services
USA
UK
GERMANY
INDIA