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Quality policy

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Basic goals of Galenika a.d. are best achieved by constantly working on assurance and improvement of product quality, efficiency and safety. At the same time this means that patient safety and satisfaction is the primary assignment of Galenika a.d. Received certificates are the proof of significance and application of high quality standards:

  • GMP certificate, issued by the Ministry of Health of the Republic of Serbia;

as well as certificates issued by the auditing company TÜV SÜD, Germany:

  • ISO 9001:2008 certificate, for integrated quality system
  • EN ISO 3485:2003/AC:2007 certificate, for medical devices
  • HACCP system application certificate, for dietary supplements.

Having applied ISO 9001:2008 standard we confirmed our ability to consistently provide products that fulfill both consumer requirements and appropriate regulations. This is how we provide a guarantee that, in accordance with current legal regulations, all business processes are performed according to defined procedures, which provide continuous supply of products of appropriate quality and safety to consumers.

Having fulfilled EN ISO 13485:2003/AC:2007 standard and MDD 93/42/EEC, we met prerequisites for CE marking of medical devices and enabled their sales in the European market.

Having implemented Quality Management System for dietary supplements and applied HACCP system, we met all prerequisites for manufacturing and supply of dietary supplements.