EMPROVE® Dossier Complete
Pharmaceutical excipients, unlike active ingredients, are still largely unregulated and requirements for safe production comparable to those of ICH Q7 do not yet exist for excipients. Because consumer safety has highest priority, Merck EMPROVE® applies appropriate standards also to excipients. Thus, EMPROVE® raw materials offer an exceptionally high level of product safety that is unique in the market.
Merck’s EMPROVE® Dossier Complete comprises the partial dossiers Basic, Analytical Procedure and Stability Data. The EMPROVE® documentation contains all fundamental data you need. Needless to say, it meets all international requirements for registering excipients.
At a price point of 7,500 EUR, you’ll get a comprehensive package that comes with annual updates, free of charge for five years after the start of the contract.
Want the dossier?
Just get in touch with our local sales companies or contact us directly. Immediately, you’ll be sent an Information Transition Agreement (ITA) to access the EMPROVE® Dossier Complete. Once you’ve signed and returned the NDA, you’ll receive the requested information.
