Nikao Life Sciences provides comprehensive product quality and risk assessment support to help sponsors anticipate regulatory expectations and ensure product safety throughout development. Our expertise spans impurity qualification, extractables and leachables evaluations, excipient justification, and advanced in silico toxicology modeling. We help teams understand the impact of formulation components, device materials, degradants, and impurities ensuring each element is supported by robust toxicological rationale and GLP/ICH-aligned documentation.
Impurities & Degradation Products
- ICH M7–aligned risk assessments
- Structural alert analysis and genotoxicity predictions
- Toxicological qualification of identified and unidentified impurities
- Threshold of Toxicological Concern (TTC) justifications
- Safety evaluations for degradants formed under stress or stability conditions
Extractables & Leachables (E&L)
- Toxicological evaluation of extractables and leachables from containers, closures, and delivery devices
- Assessment of leachable safety relative to established exposure limits
- Study design support for E&L programs
- Regulatory justification packages for device–drug combination products
Excipients & Formulation Components
- Safety assessments for novel or high-risk excipients
- Cross-referencing with allowable daily exposures (ADEs)
- Scientific justification for excipient use in new formulations
- Qualification strategy for global submissions
Predictive Toxicology & In Silico Risk Modeling
- Leadscope modeling for mutagenicity risk
- N-nitrosamine CPCA assessments and carcinogenic potency categorization
- Structure–activity relationship (SAR) evaluation
- Computational toxicology assessments to support regulatory decision-making
Quality Risk Mitigation Strategy
- ICH Q-series–aligned risk frameworks
- Identification of critical quality attributes (CQAs)
- Risk characterization and mitigation for impurities, leachables, excipients, and degradation products
- Regulatory-ready summaries and justification documents