Our expert risk assessment and impurity evaluation services ensure pharmaceutical product safety and compliance with global regulatory requirements. We provide detailed analysis of potential risks and impurities throughout the product lifecycle.
Systematic identification, analysis, and evaluation of potential risks throughout pharmaceutical product development and manufacturing processes.
Critical AnalysisDetermination of acceptable daily exposure limits for pharmaceutical ingredients and impurities based on toxicological data and regulatory guidelines.
Detailed CalculationEstablishment of safe exposure limits for pharmaceutical compounds in workplace environments to protect employee health and safety.
Safety FocusEvaluation of potential genotoxic impurities in pharmaceutical products following ICH M7 guidelines and regulatory requirements.
High PriorityComprehensive assessment of nitrosamine and nitroso impurities in pharmaceutical products, including risk evaluation and mitigation strategies.
Regulatory FocusDevelopment of comprehensive control strategies for impurities including specification setting, analytical method selection, and monitoring plans.
Proactive ApproachSystematic identification of potential hazards and impurities in pharmaceutical products
Quantitative and qualitative analysis of identified risks using scientific data and regulatory guidelines
Evaluation of risk significance and determination of appropriate control measures
Development and implementation of risk control strategies and monitoring programs
ICH Q3A, Q3B (Impurities), ICH M7 (Genotoxic Impurities), ICH Q9 (Quality Risk Management)
FDA guidance on genotoxic and carcinogenic impurities, nitrosamine impurities control
EMA guidelines on limits for genotoxic impurities, nitrosamine risk assessment
SFDA, MOH, and other regional regulatory requirements for impurity control
Contact our risk assessment experts today for comprehensive impurity evaluation and safety assessment of your pharmaceutical products.