Consulting
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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