Bioequivalence

Offering its clients the possibility of preparing complete registration documentation for generic medicinal products, KMJ pharma® Sp. z o.o. provides consultancy on planning and carrying out bioequivalence studies.

Bioequivalence studies include e.g.:

  • Preparing and approving a study report by EC (choosing a type of bioequivalence study depending on the final point of the study, preparing the strategy of the study (single, multiple), the choice of the reference product, etc.);
  • Providing the proper number of volunteers to carry out the study report;
  • Carrying out the study in accordance with the report (checking the pharmaceutical equivalence);
  • Compliance with Good Clinical Practices (GCP) and Good Laboratory Practices (GLP);
  • Preparing a final report.