Submission of Clinical Trial Applications (CTA)
Clinical trials are key factors during the entire lifecycle of a medicinal product includes lots of testing, trials, including clinical trials as well, right from the very beginning. Clinical trials are used to get new data on the human use of medicinal products continuously.
- Phase I. – tolerability, human pharmacokinetics, pharmacodynamics
- Phase II. – explorative studies (justification of the therapeutic effectiveness within tolerability dose levels, side effect profile)
- Phase III. – confirmative studies (further justification of the therapeutic effects, refining side effect profile), bioequivalence studies (study of generics)
- Phase IV. – studies performed after having valid marketing authorisation of the product (further justification of all information previously gained and authorised within tolerability dose levels)
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