We provide expert regulatory assessment for PDE (Permitted Daily Exposure) and OEL (Occupational Exposure Limit) determinations. Our team of toxicologists and regulatory specialists ensures compliance with international standards and guidelines.
PDE Assessment
Permitted Daily Exposure calculations based on non-clinical and clinical toxicology data, following ICH Q3C guidelines
OEL Determination
Occupational Exposure Limit evaluation for manufacturing environments with hazard characterization
API Categorization
Active Pharmaceutical Ingredient classification and safety assessment for handling and processing
Risk Analysis
Comprehensive toxicological evaluation of impurities and potential environmental hazards
Regulatory Guidance
Expert consultation on EMA, FDA, and ICH requirements for your specific substances
Documentation Support
Complete technical file compilation and regulatory submission preparation
Available Substance Database
We maintain comprehensive reports on the following substances. Select any to view detailed assessment information:
Request a PDE/OEL Report
Fill out the form below to request a custom assessment for your substances. Our team will contact you within 24 hours.