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Cunesoft offers a ready to use, pre-validated and highly secure cloud based regulatory compliance suite. Our software has been built to fulfil regulatory needs holistically and end to end. Our vision is to keep it as simple as possible while delivering compliance and fulfilling FDA 21CFR11, EU Annex 11, ICH, and GxP requirements.
The regulatory hurdles faced by Life Sciences companies are sometimes viewed as slowing progress. The reasons for this are compliance requirements that are being provided by health authorities to ensure patient safety and to ensure product quality. While this is perfectly fine, the consequence is that these regulations are so severe, that achieving compliance leads to very slow processes. At cunesoft, our vision is to provide intelligent automation to these processes so that our clients are better able to address the growing need for new and personalized medicines – without requiring more regulatory manpower than today. Ultimately, by helping our clients speed up their regulatory operations, better medicines will become available and mean better lives for our global community.