RadioMedic ltd. develops, manufactures and distributes the radiopharmaceutical preparations.
The company is the GMP holder of the certificate for manufacturing of the human pharmaceuticals and human pharmaceuticals in the clinical study – phase I and II.
Furthermore, RadioMedic ltd. is also the GDP holder for the distribution of the medical products and preparations in the Czech Republic with an appropriate certification.
For the both activities, the company performs ČSN EN ISO 9001:2009 certification.
RadioMedic ltd. has 5 marketing authorization licences in the Czech Republic and 2 marketing authorization licences in Slovakia for:
- positron emission tomography radiodiagnostics :
- 18F-fluordeoxyglucose (CZ, SK)
- 18F-natrium fluoride (CZ)
- 18F-fluorthymydine (CZ)
- 81mKr generators for lung diagnostics (CZ, SK)
- natrium iodide containing 123I for thyroid diagnostics by means of the single photon emission computed tomography – SPECT (CZ)
RadioMedic Ltd. has another contractual manufacturing site in Slovakia – BIONT a.s., Karloveská 63, P.c. 841 04 Bratislava.
RadioMedic ltd. has an extensive experience with the implementation of the manufacturing processes in the are of radiopharmaceuticals under the GMP, elaborating the GMP documentation and providing all the method validations which are connected with the implementation of the manufacturing technology, manufacturing processes, quality contro, quality assurance and distribution.
RadioMedic ltd. is professionaly enable to ensure the entire staff training at the current company’s manufacture site as well as at a new manufacturing site at the customer’s.
The company has its own rich and wide knowledge and experience with realization of the preclinical studies and clinical studies in the Czech Republic and marketing authorization in the Czech Republic and Slovakia as well.
The company implements all the necessary technologies in a quality which precisely meets the customer´s requirements (radiochemical precursors or radiopharmaceuticals).
In the field of the research area, the company offers cooperation and consultation sevice for the radiopharmaceutical preparation with a good potential of being applied on the pharmaceutical market – realization process from the preclinical study toward the clinical study and the final marketing authorization.
RadioMedic ltd. ensures the transport of radiopharmaceuticals by its own car with ADR .
RadioMedic Ltd. proposes, constructs and recycles the target systems for the radiochemical production in the cyclotron, sales of manufacturing synthesizing technology and quality control service.
Research project TACR
TA03010878 – Development of the new targeted radiopharmaceuticals for diagnostic and therapeutic use in nuclear medicine and their biological testing.