,Toxicological Risk Assessment (TRA) Services - Overview
Toxicological Risk Assessment (TRA) of impurities, especially potential genotoxic impurities, is essential to controlling and/or limiting their usage at unsafe levels. Toxicological Risk Assessment reports on impurities and E&L are structured scientific evaluations that involve hazard identification and risk characterization.
At Freyr, our experts use ICH-recommended and validated tools to conduct Toxicological Risk Assessments for impurities, extractables, and leachables, supporting numerous global clients with trusted, compliant solutions. We have addressed a range of simple to complex issues related to impurities in drug substances, drug products, residual solvents, process impurities, and elemental impurities.
Toxicological Risk Assessments services by Freyr:
- Genotoxic Impurities Risk Assessment in Compliance with ICH-M7
- Toxicological Risk Assessment of Impurities in Drug Substance (ICH Q3A) and Drug Products (ICH Q3B)
- Toxicological Risk Assessment of Residual Solvents (ICH Q3C)
- Toxicological Risk Assessment of Elemental Impurities (ICH Q3D)
- Toxicological Risk Assessment of Extractables and Leachables (E&L) from Container Closure System (CCS)
- Impurities in Veterinary Medicinal Products (VICH GL18)
Toxicological Risk Assessment (TRA) Services
- Understand the issue clearly and develop an appropriate strategy in consultation with the Sponsor.
- Use highly scientific approaches and methodologies, including read-across strategies/approaches, to fill the data gaps.
- QSAR evaluation using well-validated and Regulatory-accepted software tools, according to the recommendations of ICH M7 (statistical and rule-based expert assessment).
- Expert reports generated by ICH M7 with complete supporting data/information and reports reviewed/approved by qualified toxicologists.
- Toxicological Risk Assessment and Derivation of Acceptable Daily Intake (ADI) for ‘out-of-specification’ impurities, including non-ICH Q3D elemental impurities.
- Planning and designing nonclinical studies to qualify 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).
- Highly experienced and board-certified team (American Board of Toxicology and European Registered Toxicologists).
- Clear understanding of the Toxicological Risk Assessment process for impurities and E&L with relevant Regulatory guidelines.
- 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, summary reports with ‘Go-No-Go’ decisions.
- Well-established and structured literature search strategy.
- Robust quality control checks, from document compilation to sign-off.
- 24x7 Regulatory support for audit queries on Toxicological Risk Assessment reports.
