Impurity safety assessments
General impurity and degradation product safety assessments, safety based specifications, Permitted Daily Exposure (PDE) derivation according to ICH impurity guidelines, safety assessments of contaminations; solvent and elemental impurity assessments, Tolerable Intake (TI) derivations for medical devices
Extractables & Leachables
Material qualification (packaging, process equipment, devices), including input to analytical design (AET derivation), data interpretation, and safety assessments of identified substances acc. to ICHQ3E and ISO10993-17
In silico toxicology
Hazard prediction based on read across and in silico toxicology tools (incl. mutagenicity assessment according to ICH M7) using both public and commercial (Leadscope Model Applier) software, expert judgment on in silico tool and AI output
Literature based assessments
Expert reports for formulation development, excipients safety, limits for carry-over cross-contaminations (PDE for active ingredients), occupational safety evaluations (Occupational Exposure Limits/Banding), safety data sheets for chemicals/products