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

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