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Not only do we set high standards for
our business, but we also take responsibility for the
validation of our manufacturing instructions.
We already comply with the demands of
all national and European regulations.
With our experienced QS-Team we have
got the FDA approval in June 2006 by the beginning of 2005.
We have introduced a LIMS-system; we
have validated our ERP-system according to GAMP4 and we
have invested in water treatment plant and manufacturing
facilities to comply with the strict requirements of the
FDA.
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audits |