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