Our scientific risk assessment services provide the data-driven foundation for your validation and safety strategies. We specialize in Permitted Daily Exposure (PDE) calculations, Occupational Exposure Limits (OEL), and comprehensive impurity profiling to ensure patient safety and regulatory compliance (ICH Q3D, ICH M7).
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 cross-contamination risks in shared facilities.
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
Calculation of health-based exposure limits (HBELs) for cleaning validation and worker safety. View our specialized PDE Calculation Reports.
FDA guidance on genotoxic and carcinogenic impurities, nitrosamine impurities control
EMA guidelines on limits for genotoxic impurities, nitrosamine risk assessment
Comprehensive report including PDE/OEL values, references, and expert statement
PDE (Permitted Daily Exposure) is the maximum acceptable intake of a substance for a patient, while OEL (Occupational Exposure Limit) determines the safe exposure level for workers during manufacturing.
Yes, OEL determination is mandatory for worker safety assessments (COSHH) regardless of facility dedication, though cross-contamination risk (PDE) might be lower.
Yes, we conduct comprehensive Nitrosamine Risk Assessments in compliance with FDA and EMA requirements, evaluating raw materials, packaging, and manufacturing processes.
Yes, our risk assessment reports for PDE, OEL, and elemental impurities are prepared according to ICH guidelines and are fully accepted by SFDA, EDA, and other regulatory bodies.
We follow ICH M7 guidelines, using computational toxicology (QSAR) and database searches to classify impurities and determine appropriate control limits.
Contact our risk assessment experts today for comprehensive impurity evaluation and safety assessment of your pharmaceutical products.