Safety Testing/Toxicology

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 you in:

  • 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" (MABEL).