CS Develops, manufactures and distributes radiopharmaceuticals
It holds a GMP (Good Manufacturing Practice) certificate for human medicinal products and human investigational medicinal products, a GDP (Good Distribution Practice) certificate, and a manufacturing authorisation for human medicinal products and human investigational medicinal products. The manufacture and distribution of medicinal products are certified to ČSN EN ISO 9001.
Radiopharmaceuticals for diagnostics
- Authorized medicinal products
- Medicinal products under the Specific Treatment Programme
RadioMedic s.r.o. has experience in setting up radiopharmaceutical manufacture under the Good Manufacturing Practice (GMP) regime, in preparing all documentation in compliance with GMP, and in carrying out validations of both processes and equipment for manufacture and quality control.
The company is able to provide comprehensive training of personnel for a new manufacturing site at its own premises and, according to customer requirements, also at the new manufacturing site.
It has its own experience with conducting preclinical and clinical studies in the Czech Republic, as well as with the authorization of medicinal products in the Czech Republic and Slovakia.
It provides a broad range of quality-control laboratory services in the field of analytical and microbiological testing.
In the field of research, it offers cooperation on selected radiopharmaceutical preparations, from conducting preclinical testing through clinical trials to final authorization of the product.
It provides transport of radioactive materials in its own vehicles.
The company also engages in the design, construction and recycling of target systems and handling equipment for processing radiochemicals prepared by irradiation on a cyclotron and in a reactor.
