We have provided advice, training and quality systems development to aid clients that are interested in producing materials intended for use as APIs.
Several of our clients were producing materials intended for use as excipients or food additives. They enlisted our services to expand their market base by assessing their deficiencies to ICH Q7 and FDA regulations and providing a project plan to remediate their current processes and procedures to meet FDA requirements.
Project plans were implemented and effectiveness of the new process and procedures were assessed.
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