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Commitment to quality

areta international is a company highly focused on quality, constantly pursued and maintained according to the Quality System, the basis of its work philosophy. The Quality policy is defined in the Quality Manual. The management evaluate periodically the performance in order to improve its system and to better satisfy customer requirement even if not explicitly described in the contracts. All personnel is trained and operates according to internal procedures, a Quality Assurance is in charge to ensure the accordance to the Quality System, to collaborate with colleagues to better define solutions and to operate in compliance with the ISO and GMP requirements when needed.

The ISO certificate, received and maintained since 2000 through periodical updates, covers all the company's work, from project management through continued monitoring and up to the project's completion.
The manufacturing facility, authorized by AIFA to produce and release biological products for clinical trials, works in accordance with the current European GMP requirements.

The Quality System is guaranteed by a quality team, constantly updated and coordinated by the QP [Qualified Person] who works in perfect synergy with the production team. All the company's personnel takes part in a permanent training programme and works according to the internal procedures.

The consolidated experience acquired in the field of biologicals enables areta to offer its customers consultancy services in both the Regulatory Affairs and Quality sectors. Preparation of SOP, Validation Master Plan, audit, training, Site Master File, Drug Master File, Investigational Medicinal Product Dossier are only a few examples of areta's activities in this field.

areta is constantly visited and subject of audits by both acquired and potential customers. This allows areta's Quality System to be often tested in always different settings and continuously improved.

 

 
 
 

areta international S.r.l | via R. Lepetit, 34 | 21040 Gerenzano (VA) Italy
Tel: +39 02 96474804 | Fax: +39 02 96474800 | P.iva: 12914940155 | Share capital € 709.249,00