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About Radiopharma Solutions Fzco

Planning and consultancy services for radio pharmacies From green field to batch release : Our team will assist you with the implementation project of your radiopharmaceutical facility, starting from the design phase, with great competence and in full compliance with the GMP regulation. Design and Implementation : Thanks to our staff’s engineering, pharmaceutical and managing skills, we are able to design a radiopharmaceutical facility, while providing various services such as plans, perspective drawings and technical reports. We also follow through on all the construction stages, from site set-up to final implementation of the facility. GMP quality system implementation : We offer our experience and expertise in the radiopharmaceutical sector and provide experts in the field of QA for the QMS implementation and assessment. Our support activities encompass the management of standard documentation and raw materials, as well as the qualification of suppliers, equipment, staff, changes, deviations, off-specification items and inspections. In addition to the above mentioned activities, we also provide customized solutions according to the customer’s specific needs. Qualification and validation : We carry out qualification activities for classified rooms, isolators, hotcells for radiopharmaceutical handling or dispensing, shielded cells for synthesis modules, synthesis modules, autoclaves, pass-through boxes / materials, refrigerators and climatic chambers. Furthermore we also perform cleaning and process validation activities. All these activities are performed by trained staff who have extensive knowledge in radioprotection measures and certified equipment. Production start-up : We will assist you during all phases in the initial production stage. Management activities : In the case of facilities authorized to operate abroad, our staff also takes care of the site’s management. Training We offer technical training for radiopharmacy personnel.

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