Nowadays, an emerging number of advanced therapies improve patients’ quality of life. Nanotechnology-related drug products are at the forefront of this development. Still the translation of nanomedicines from bench to bedside poses a major challenge to the scientific community. Key challenges arise from the bioanalytical methods required to characterize nanomedicines in preclinical and clinical studies. Major hurdles in the development of novel drug delivery systems and their translation into the hospital will be discussed from the perspective of a pharmaceutical scientist.