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Regulatory compliance

CUNESOFT, A PHLEXGLOBAL COMPANY

Germany

Cunesoft offers a ready to use, pre-validated and highly secure cloud based regulatory compliance suite for Life Science Industry. This includes solutions like: eCTD, IDMP, RIM, RDMS, SOP, Data Mining and others. 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.
KLOTZ GRASSINGER GRUPPE

Germany

Distinguished by completely digital machine technology (IKA®) and perfect cGMP compliance, the KLOTZ GRASSINGER group of companies are medium-sized German enterprises that specialise in the development and production of all types of liquids applied to the skin. Our company remains resolute in the face of uniformity and the desire to follow the latest trends as it seeks to set standards with products and processes that are committed to sustainability. Thanks to our machine technology (IKA®), we are able to develop products tailored to your specific needs within the shortest possible time, to document them as pilot runs ready for the market and, if successful, to produce them in large series. Our quality standards are to your benefit: All our production processes are internally validated and externally certified according to the latest cGMP guidelines. Thus, we fulfil all regulatory obligations from the EU/U.S. FDA/CHINA/JAPAN and elsewhere.

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Regulatory compliance

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2 Companies