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), and Acceptable Intake (AI).
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.