First-tier testing

E. coli bacteria

Modest cost, fairly predictive

Typically, first-tier safety tests are far less costly and take less time than second-tier tests that may follow. But first-tier tests can be rather predictive. They provide useful information that helps in making decisions on timing, on investments, on further testing, on dossier preparation and on overall business development strategy.







Services provided for first-tier testing may include, for instance, one or more of the following:

  • selection of testing laboratories (based on experience with over 2,000 contract studies in toxicology, analytical chemistry, nutrition, pharmacology and microbiology, from 1990 onwards)
  • monitoring of contract studies (for instance: in vitro genotoxicity screening or full testing, pilot study for repeated-dose toxicity)
  • product characterization (analysis of chemical composition, chemical impurities microbiology)
  • consulting with authorities
  • consulting with external experts on specific issues
  • adapting test strategy if necessary and defining second-tier tests 
  • further defining elements of a dossier for registration
  • adapting the tentative time schedule towards market introduction, if necessary
  • estimating the costs of testing and further safety/regulatory development
  • estimating overall feasibility and chance of success
  • providing a basis for further decisions