| Quality and regulatory support |
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With ten years experience in the field of biologics, areta can support its customers both in Quality and in Regulatory aspects. Elaboration of Validation Master File, SOP, audit, training, Site Master File, Drug Master File, Investigational Medicinal Product Dossier are some examples of areta activities. Every project is customer oriented and focused on its needs. The know-how and the continuous training permit areta’s team to support the customer during all the phases of a clinical trial. Quality policyareta is a company highly focused on quality, in order to have a Quality System, ISO certification was obtained in 2000 and maintained ever since. Quality policy is defined in the Quality manual. The management evaluates periodically the performance in order to improve its system and to better satisfy the customer requirements even if not explicitly described in the contract. An effective project management ensures high quality, rapid and efficient results in full compliance with the Italian and European regulatory requirements. Quality teamareta's quality team is formed by highly qualified personnel from different fields: biology, biochemistry, chemistry, pharmaceutical chemistry, biotechnology. This wide range of expertises ensures the right flexibility and an effective know-how, sharing its own expertises allow to have ideas, innovation and project success. The highest priority and emphasis is placed on the customer satisfaction and its needs. |