Bioequivalence studies

Smooth Drug Development conducts full service registrational bioequivalence trials.

To get a generic drug registered in Russia it is necessary to submit results of pre-clinical (literature data can be submitted) and local clinical trials.

Due to a well-coordinated team of professionals, partnership with clinical sites and bioanalytical laboratories, we guarantee quick study performance with high quality of data and documents.

Clinics selected by us meet all requirements set to providers of bioequivalence trials and have modern equipment. Reports are prepared in accordance with latest requirements and guidelines of the Ministry of Health of the Russian Federation.

Smooth Drug Development partners with a leading clinical research site in Russia. The site has 50 beds and database of 3000 healthy volunteers.

Approximate timelines of a bioequivalence trial are 3 months from clinical trial approval to clinical study report.

If needed, our team perform bioequivalence trials in patients and special populations.

Smooth Drug Development has been providing a full spectrum of bioequivalence trial services since 2011.