We offer our experience and expertise in the radiopharmaceutical sector and provide experts in the field of Quality Assurance for quality system 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 abovementioned activities, we also provide customized solutions according to the customer’s specific needs.
Moreover, our experts carry out a wide range of auditing activities, in order to assess compliance of the site with the GMP regulations. After all these activities are provided, a final report will be issued including the general state of the system, along with any situations of non-compliance and the proposed action plan to achieve fully regulatory compliance.