,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 Assessments reports of impurities and E&L are structured scientific evaluations involving hazard identification and risk characterization.
At Freyr, our experts utilize ICH-recommended and validated tool to conduct Toxicological Risk Assessments for impurities, extractables, and leachables -supporting numerous global clients with trusted and complaint solutions. We have addressed several simple to complex issues associated with 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.
