Consulting

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We offer consulting services in the field of:

  • planning the scope of preclinical studies
  • analyzing the results of performed preclinical studies
  • preparing strategies and study outlines
  • defining main study assumptions
  • ensuring compliance of a study conduct with current European (EMEA) and American (FDA, HPB) guidelines and with ICH
  • evaluating documentation with regard to its usefulness in trial commencement and product registration
  • searching for the optimal efficacy and safety evaluation methods of a new medicinal product

 

 

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