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Our Certifications

PrecisPharma is proudly certified by the leading quality registrar, TÜV SÜD. Our Quality Management System is recognized with the following certifications:

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EN ISO 13485:2016

EN ISO 13485:2016 for Production and supply of Dosing syringes & Measuring Cups for oral dispensing of medicines.

ISO 15378:2017

ISO 15378:2017 for Production and Supply of plastic bottles and closures as primary packaging materials by molding for pharmaceutical use.

US FDA Type III DMF

US FDA Type III DMF holder (DMF No. 034858)

European Medical Device Regulation

European Medical Device Regulation 2017/745 on medical devices.

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