www.rednucleus.com contact us at info@rednucleus.com Case Study R&D REGULATORY TEMPLATES, STANDARDS & NAMING CONVENTIONS Client Challenge Several pharmaceutical companies (from small to large) have had a need to streamline their regulatory operations by developing and implementing submission (and other supporting) templates, standards, and naming conventions. These improvements would ultimately optimize regulatory submission processes. Red Nucleus Solution For one client in particular, the Red Nucleus team worked with R&D functions to develop a suite of 350+ submission templates. The templates followed the electronic common technical document format and provided the required information per the International Council for Harmonisation guidelines. The templates were loaded within the

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