Company Profile
Company RadioMedic ltd. deals with the development, manufacturing and distribution of the radiopharmaceutical preparations. The company is holder of the GMP Certificate for manufacturing of the human pharmaceutical and human pharmaceutical in clinical study in the phase I, II and III.
RadioMedic ltd. has a contractual manufacturing place in the Slovak Republic – BIONT, a.s., Karloveská 63, 841 04 Bratislava, where the company manufactures one of the radiopharmaceutical with the slovak marketing authorization. The company holds 5 radiopharmaceuticals with the marketing authorization in the Czech Republic and 2 radiopharmaceuticals with the marketing authorization in the Slovak Republic.
The company manufactures the radiodiagnostics for positron emission tomography (PET) labeled by positron isotope 18F, generators producing 81mKr as a lung diagnostics and natrium involving 123I as a thyroid diagnostics by means of the single photon emission computed tomography (SPECT).
RadioMedic ltd. has a huge experience with the implementing of the manufacturing process of the radiopharmaceuticals in the GMP mode, elaborating the GMP documentation and providing all the method validation which are connected with the implementation of the devices to the manufacturing technology, manufacturing process, quality control and quality assurance. RadioMedic ltd. is enable to attach the whole staff training for new manufacturing place at the current company manufacturing place as well as at the new manufacturing place at the customer. The company implements the whole necessary technology in such a quality according to the customer´s requirements (radiochemicals or radiopharmaceuticals).
In the research area, the company offers cooperation and consultancy for the selected preparation with the good potential to be applied at the pharmaceutical market - realization process of the preclinical study, clinical study and the final marketing authorization.
The company has an own rich knowledge and experience with realization preclinical study and as well clinical study in the Czech Republic and in the Slovak republic.
Other region of interest is connected with the proposal, construction and recyclation of the target systems for the radiochemical production at the cyclotrone, sale of the manufacturing synthesizing technology and manipulating device for irradiated radiochemicals and quality control service.