We have extensive experience in safety testing of small molecules (NCEs), biologics (NBEs), biosimilars, ATMPs including cell and gene therapeutics, and vaccines. So we'd be thrilled to support
molecular and indication-specific design of your preclinical safety testing program (toxicology and safety pharmacology), both for entry into phase I clinical testing and to accompany
subsequent clinical development
identifying the best fit CRO for your studies
designing studies and determining test doses
communicating with the CRO
monitoring study performance, including the final report
determining the Maximum Recommended Starting Dose (MRSD) for first human application, based on the "No Adverse Effect Level" (NOAEL) or the "Minimum Anticipated Biological Effect level"