… where Chemistry meets Biotechnology
Thanks to our well-established experience in product development and biochemical manufacturing Pharma Waldhof has access to virtually every kind of common organic and enzymatic reactions and bioconversions.
The ongoing technical partnership with selected biochemical companies around the world offer Pharma Waldhof a wide range of manufacturing and process development facilities for active ingredients, key intermediates and reagents from the small laboratory and typical pilot scale to the larger commercial scale.
All manufacturing units for drug substances and key intermediates meet the current national and supranational regulatory requirements, i.e. comply with the current GMP standards, with ICH Q7A and other EU or German guidelines and regulations, and are regularly inspected by both the US Food & Drug Administration and other competent authorities.
Pharma Waldhof is ISO9001:2008 and cGDP certified.