Overview Expertise Advantages Testimonials Overview Toxicological Risk Assessment (TRA) is a comprehensive safety evaluation report for a specific ingredient or contaminant in a product. TRA is a detailed scientific assessment report prepared by an expert toxicologist based on sound scientific knowledge on all the available information/data about the specific ingredient within the context of the 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 to many clients across the globe. Freyr Expertise PHARMACEUTICALS Safety evaluation and assessment of pharmaceutical excipients as 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 DEVICES Biocompatibility safety assessment of medical devices as per their intended surface contact and duration vide ISO-10993 Safety evaluation and Regulatory support for extractables and leachables COSMETICS Safety assessment of cosmetics and their individual ingredients Human risk assessment and individual hazard assessment of flavours and fragrances CONSUMER PRODUCTS Toxicological risk assessment and exposures calculation for various consumer products viz e-cigarettes, single and multi-component ingredients, or mixtures, etc. FOOD Toxicological risk assessment of food-contact material migrants and derivation of oral Tolerable Daily Intakes (TDIs) Derivation of Health Criteria Values (HCVs) for substances present in food Assessing the hazards of natural compounds associated with food contamination Recommending a TDI for a contaminating pesticide GENERAL CHEMICALS Complete safety reports for the chemicals per various regulations like the REACH GHS classification services SDS/MSDS services Handling and assessment of the safety of hazardous chemicals Freyr Advantages Board-certified team of toxicologists with vast experience in toxicological risk assessment Clear understanding of various Regulatory guidelines and processes for multiple products Comprehensive reports encompassing detailed evaluation and assessment of various hazards Quick turnaround and priority delivery based on the urgency and requirement of the client On-demand short-summary reports with ‘Go-no-Go’ decisions Well-established and structured literature search strategy Robust quality control checks right from document compilation to sign-off stages
