Designing research and project consulting.
Preparation of study protocols in compliance with the international standards.
Support in selecting the appropriate clinical center.
Carrying out bioanalyses in a lab that holds the GLP certificate:
- method development for determination the parent drug or its metabolites in biological material,
- validation of the method in accordance with the EMA and FDA requirements,
- determination of concentrations in biological samples,
- preparing a validation and a bioanalytical report.
Substantive analysis of results covers:
- calculations and pharmacokinetic analysis,
- analysis and statistical conclusions.
Preparation of the Final Study Report in the form that is compliant with the requirements of the CTD.
Consultation of the registration dossier for medicinal product, preparation of expertise and opinion on bioavailability and bioequivalence.