Impurity safety assessments
General impurity safety assessments, safety based specifications, Permitted Daily Exposure (PDE) derivation according to ICH impurity guidelines, safety assessments of contaminations; solvent and elemental impurity assessments
Extractables & Leachables
Material qualification (packaging, process equipment), including input to analytical design (AET derivation), data interpretation, and safety assessments of identified substances
In silico toxicology
Hazard prediction based on read across and in silico toxicology tools (incl. mutagenicity assessment according to ICH M7)
Literature based assessments
Expert reports for formulation development, excipients safety, limits for carry-over cross-contaminations, occupational safety evaluations