Toxicological Risk Assessment (TRA) – An Overview

Impurities in medicinal drug substances (API) or medicinal drug products, including Extractables and Leachables (E&L), not only affect the product quality but also pose a significant risk to the patient population. Toxicological Risk Assessment (TRA) of impurities, especially potential genotoxic impurities, is essential to control and/or limit its usage at unsafe levels.

Toxicological Risk Assessments of impurities and E&L are structured scientific processes involving hazard identification and risk assessment. For such risk assessment, ICH M7 recommended and validated tools are used in pharmaceuticals under the purview of Toxicological Risk assessment services.

Freyr’s toxicologist team under Toxicological Risk Assessments services has supported numerous global clients and addressed the issues associated with Toxicological safety Assessment and impurities in drug substances, drug products, residual solvents, process impurities and elemental impurities. 


Toxicological Risk Assessment (TRA) - Freyr Expertise

  • Quality scientific and read-across strategies/approaches.
  • QSAR evaluation by using well-validated and Regulatory-accepted software tools by ICH M7 (statistical and expert rule-based evaluation).
  • Expert reports generated by ICH M7 with complete supporting data/information.  
  • Toxicological Risk Assessment and Derivation of Acceptable Daily Intake (ADI) for ‘out-of-specification’ impurities, including non-ICH Q3D elemental impurities.
  • Planning and designing of nonclinical studies for the qualification of impurities, including placement, monitoring, and review of study reports for Regulatory submissions.
  • E&L risk assessment in Pharmaceuticals and Medical Devices (ISO10993-17, ISO10993-18, and ISO/TS 21726).   

Toxicological Risk Assessment (TRA) - Freyr Advantages

  • Highly experienced and board-certified team (American Board of Toxicology and European Registered Toxicologists).
  • A clear understanding of Toxicological Risk Assessment and E&L-relevant Regulatory guidelines and processes.
  • Comprehensive Toxicological Risk Assessment reports, encompassing detailed evaluation, hazard identification, and risk assessment.
  • Quick turnaround and priority delivery based on the urgency and requirement of the customer.
  • 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 the sign-off stage.
  • 24x7 Regulatory support for audit queries on Toxicological Risk Assessment reports.