Signe Stige Hansen
Senior Toxicologist
Senior Toxicologist
Saxocon
Denmark
Biography
"Senior Toxicologist at SAXOCON that offers toxicological assessment services: Pharma/Biotech • Assessment of Impurities in drugs - according to ICH M7 • Non-GLP impurity screening with QSAR • Metabolite screening • Customized QSAR models • Clinical Study Reports and submission documents • Investigator’s Brochures - according to ICH E6 (GCP) • Nonclinical Sponsor study Monitoring (GLP) • Combination product: Drug Delivery Device Medical Device • Biological Safety Evaluation - according to ISO 10993:2009 • Material Changes – update of Biological Safety Evaluation • Batch Control • Sponsor study Monitoring (GLP) • Combination product: - Medical Device incorporating • External Tox Department Food • Support for testing of ingredients o Planning o Dose o Sponsor study Monitoring (GLP) o Report according to EFSA "
Research Interest
Veterinary, Veterinary Medicine, Parasitology.
