EMPROVE® designed to be ahead
Customer issue
In the past, our customers’ most important criterion for selecting the products they use in a pharmaceutical production process was the pharmacopoeia. But in the meantime, legislation is requiring more extensive documentation for the registration and renewed registration of pharmaceuticals. Not all of your suppliers have developed the necessary expertise to provide you with complete, accurate and updated dossiers on the products you use – and that’s where Merck’s tradition of attention to detail can help you meet your needs.
EMD’s solution
EMPROVE®, the new top brand for raw materials for the pharmaceutical production process, is the name for Merck’s combined package of product and support services. Its objective is to combine Merck’s excellent product quality with comprehensive services around its products. Our current focus is on developing intelligent support services for documentation.
An EMPROVE® dossier makes use of the Module 3 Common Technical Document (CTD) format, used today by regulatory authorities in the US, Europe and Japan to describe the data needed for a marketing authorization dossier. It complies with the most recent International Committee of Harmonization (ICH) guidelines to ensure comprehensive and complete documentation. A complete EMPROVE® dossier contains everything you need to file marketing authorization applications for the excipients used: monographs, descriptions of manufacturing procedures and stability data. Updates are guaranteed for a period of five years for the complete EMPROVE® dossier. The EMPROVE® dossier is also available in the form of individual modules – partial dossiers – without any updates.
Benefits for you
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EMPROVE® is convenient and saves time in quality control and quality assurance |
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EMPROVE® reduces cost by simplifying and shortening regulatory and quality processes |
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EMPROVE® increases product safety |
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