Toxicological Risk Assessment
Toxicological Risk Assessments (TRAs) involving hazard identification and risk assessment of impurities including APIs, Extractables and Leachables (E&L), especially potential genotoxic impurities, is essential to control and/or limit the safe levels to ensure the product quality but not pose a significant risk to the patient population are employed by ICH M7 recommendations.
With their vast experience, toxicologists have supported numerous global clients and addressed the issues associated with impurities in drug substances (ICH Q3A), drug products (ICH Q3B), residual solvents (ICH Q3C), process impurities, elemental impurities (ICH Q3D) including TRA of genotoxic impurities (ICH M7), and E&L.
REVIVE Motto
- QSAR evaluation by using well-validated and Regulatory-accepted software tools by ICH M7 (statistical and expert rule-based evaluation)
- Expert report by ICH M7 with full supporting data/information
- TRA 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 of Pharmaceuticals and Medical Devices (ISO10993-17, ISO10993-18, and ISO/TS 21726)
REVIVE Advantages
- Comprehensive reports encompassing detailed evaluation and assessment of various hazards
- Quick turnaround and priority delivery based on the urgency and requirement of the client
- 24×7 support for Regulatory and audit queries