Quality Agreement Template (Exclusive Substances)Quality Agreement • July 27th, 2020
Contract Type FiledJuly 27th, 2020Scope: APIs or intermediates exclusively made for one customer under a toll manufacturing contract as to EU GMP Guide Part I, chapter 7 or ICH Q7, chapter 16 (“Contract Manufacturing”, also known as “Custom Synthesis”), including substances still under development resp. for use in clinical trials.