Overview

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 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 DEVICES

  • 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

  • Safety assessment of cosmetics and its 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

FOOD

  • Toxicological risk assessment of food-contact material migrants and derivation of oral TDIs
  • Derivation health criteria values (HCVs) for substances present in food
  • Assessing the hazards of natural compounds associated with food contamination
  • 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
  • Handling and assessment of 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 various products
  • Comprehensive reports encompassing detailed evaluation and assessment of various hazards
  • Quick turnaround and priority delivery based on urgency and requirement of the client
  • On demand short summary reports with ‘Go-no-Go’ decision
  • Well established and structured literature search strategy
  • Robust quality control checks right from document compilation to sign-off stages