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EMPROVE® Comprehensive Data for Regulatory Filings
In the past, our customers' most important criterion for selecting the products
they use in a pharmaceutical production process was the pharmacopoeia. However, legislation
is requiring more extensive documentation for the registration and renewed registration of pharmaceuticals.
To help you meet these increasingly stringent requirements, EMD provides you complete, accurate
and updated dossiers on the products you use.
EMPROVE®, the new top brand for raw materials for pharmaceutical production,
is EMD's combined package of high quality product and comprehensive support documentation and services. 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.
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A complete EMPROVE® dossier contains all the data that is needed 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.
EMPROVE®:
• is convenient and saves time in quality control and quality assurance
• reduces cost by simplifying and shortening regulatory and quality processes
• increases product safety
Please click here for a sample EMPROVE® dossier. For more information,
please contact us. |
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