ico qualityQUALITY CERTIFICATION
isoMEDICAL DEVICES and FSMP
ico qualityREGULATORY COMPLIANCE

Europharma Alliance is a holder of FSSC 22000 certificate issued by TÜV Rheinland Cert GmbH,
a leading provider of technical services worldwide. The FSSC 22000 Food Safety System Certification provides a framework for effectively managing organization’s food safety responsibilities. FSSC 22000 is based on existing ISO Standards and demonstrates that company has a robust Food Safety Management System in place that meets the requirements of customers and consumers.

Europharma Alliance has implemented an ISO 13485 system for Medical Devices which is integrated with FSSC 22000 and serves as an extension to the latter.

This enables the company to offer product development and contract manufacturing of both food supplements and medical devices.

Europharma Alliance provides under Technical Agreements all necessary measures to bring the products of our clients to the compliance with current EU food safety regulations. This includes product risk assessment, control of environment impurities, stability testing. All the stages of production, warehousing as well as transportation are monitored for temperature and humidity. Batch records and retention samples are stored in controlled conditions. All routine checks are performed in our in-house laboratory, more complex tests are made in independent GLP laboratories.