Waters Nugenesis SDMS
Optimizing Efficiency with Electronic Regulatory Submissions
A large generic pharmaceutical company has research, development, manufacturing and distribution operations worldwide, including North America, South America, Europe, Asia and Australia.
This pharmaceutical company's ongoing goal is to maximize return on investment in R&D by reducing the time required to develop and commercialize new products.
A number of strategic initiatives have been launched to accomplish this goal, including the implementation of Waters® Laboratory Informatics solutions. Waters NuGenesis® Scientific Data Management System (SDMS) plays a vital role in automating scientific data entry into the company's Electronic Common Technical Document (eCTD) standard electronic format for regulatory submissions.
The eCTD is a new and advanced method used by pharmaceutical companies to assemble and submit regulatory submissions to regulatory bodies around the world, including the U.S. FDA,
Health Canada, Japan's Ministry of Health, Labor and Welfare, and the European Union's European Medicines Agency.
This represents a unique set of challenges for electronic .....
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