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Tox By Design offers a range of toxicological expertise to ensure the safety and efficacy of your pharmaceutical and biotech products. Our expert toxicological team offers assistance to biotech companies during the industrial implementation of New Chemical Entities and New Biological Entities following ICH guidelines through toxicological risk assessment and evaluation. We can guide you through every step of the EU’s mandatory ICH impurity report and provide assistance if you have an impurity that goes out of specification. Tox By Design can also assist you by: - Calculating a temporary HBEL using in-silico (QSAR) results - Updating your HBEL as toxicology study results become available - During New Chemical Entity (NCE) or New Biological Entity (NBE) development, we can also develop & update OELs, PDEs and SDSs packaging