Toxicological & chemical safety assessment
Determining safe exposure limits for impurities, extractables, contaminants, and raw materials is critical for regulatory approval. Increasing focus on Permitted Daily Exposure (PDE) and Acceptable Intake (AI) thresholds demands robust toxicological justification. Our expert toxicologists, including European Registered Toxicologists (ERT) provide expert risk assessment, threshold calculation, and regulatory documentation aligned with EMA, FDA, and ICH guidance.
We support pharmaceutical, biotech, and medical device companies in ensuring chemical safety, compliance, and submission readiness.
Scientific calculation of toxicological thresholds including Threshold of Toxicological Concern (TTC) Permitted Daily Exposure (PDE), Acceptable Intake (AI), and Analytical Evaluation Threshold (AET).
Toxicological risk assessment & expert reports
Preparation of expert toxicological risk assessments supporting regulatory submissions, variations, and audit readiness.
PFAS evaluation
Regulatory preliminary risk assessment of PFAS-contamination in packaging, raw materials, and pharmaceutical formulations.
SDS / eSDS preparation
Preparation and regulatory review of Safety Data Sheets (SDS) and extended SDS in compliance with REACH,CLP and GHS regulations.
Impurities Toxicological Assessment
We provide comprehensive toxicological assessment of impurities, evaluating their safety profile against regulatory thresholds (e.g. ICH Q3A/Q3B, ICH M7) and defining acceptable limits based on risk.
Our approach supports impurity qualification, risk assessment, and regulatory justification to ensure patient safety and compliance.