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