Pharmacokinetics / Bioequivalence / Bioavailability

Designing research and projects.

Development of test protocols in line with international standards.

Help in choosing the right clinical center.

Conducting bioanalytics in a GLP-certified laboratory:

• developing a method for the determination of unchanged substance or metabolites in biological material,
• method validation according to EMA and FDA requirements,
• markings,
• preparation of a validation and analytical report.

Substantive preparation of the research results:

• calculations and pharmacokinetic analysis,
• statistical analysis and inference.

Preparation of a complete Final Report in a format meeting the requirements of the CTD.

Consultation of documentation submitted for registration, preparation of an expert opinion and issuance of an opinion in the field of bioavailability and bioequivalence tests.