Rigorous Quality Assurance.
True quality assurance is a cultural commitment. Our quality system is based on cGMP practice, and is designed to deliver predominantly clinical trial APIs in accordance with ICHQ7 requirements.
However, quality costs and cGMP does require more documentation. We know our clients have fixed budgets and, at times, narrow margins. That’s why we have adopted a 'right first time' approach to our quality system.
Documentation: A serious responsibility and a valuable source of progress
Working in small teams, with oversight from lead senior scientists, we openly and proactively discuss expectations to ensure we deliver the needed level of quality for the best price.
We understand the importance of documentation and nothing is left to chance. Our system is designed to carefully manage the large volumes of quality documentation required for IND submission. We have good record management and can find documents at a moment’s notice.
"Part of my job is to analyze historical documentation to ensure we follow decision-making processes accurately and responsibly. Magic often happens in early-stage development projects where much is still to be validated. We have the expertise to pinpoint those unknowns, the systems to record and manage them, and the experience to incorporate the lessons that documentation can teach us."
-Quality Manager, GlycoSyn