Generic Drugs
Impurities, degradants, solvent residues, leachables, and extracts in Drug Substances and Drug Products require qualification in accordance with USP and the International Conference on Harmonisation (ICH) required by US FDA’s Office of Generic Drugs “Guidance for Industry” issued in June 2009.
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REACH
The REACH program has been initiated in the European Community and will have a profound effect worldwide. We are qualified and ready to assist you with the many activities required by this far-reaching initiative.
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