EMPROVE® exp for use as excipient
Comprehensive documentation saves you time and money
| Your benefits | |
|---|---|
|
|
- Emprove exp – Your tool for excipients
As drug approval procedures grow ever stricter, regulatory requirements are becoming more and more demanding for excipients as well. Our high-quality EMPROVE® exp raw materials for use as excipients not only comply with all relevant regulations – EMPROVE® exp products also come with detailed, usage-specific documentation facilitating lower costs of qualification and registration processes, and faster time to market.
EMPROVE® exp – detailed documentation ready to use
The EMPROVE® exp dossiers are specifically compiled in order to support excipient qualification and the drug registration process. EMPROVE® exp dossiers contain, among others, comprehensive information on the manufacturing process, testing procedures, and stability data, and are structured according to the Common Technical Document (CTD) module 3 format. By granting instant access to the required information, EMPROVE® exp will greatly reduce your workload and costs and considerably accelerate your qualification and registration processes.
EMPROVE® exp - benefit from our expertise!
With EMPROVE® exp, you benefit from Merck’s proven expertise and reputation for uncompromising reliability and safety – so you can be certain that your documentation is comprehensive. Our EMPROVE® exp raw materials for use as excipients offer specifications in accordance with the requirements of different pharmacopoeias. Cross-validated analytical methods and long-term stability studies are available as well.
Choose your EMPROVE® exp dossier
The EMPROVE® exp documentation comprises information on the manufacturer, analytical procedures (monograph), and specification as well as a description of the manufacturing process, details on impurities, stability data, and a Certificate of Analysis.
If you do not need all the information available, you can download our basic dossier from the Merck4Pharma web portal free of charge. In addition, you can order our partial dossiers on analytical testing procedures and/or stability data or our complete EMPROVE® exp dossier.
| EMPROVE® exp dossiers and prices | ||||
|---|---|---|---|---|
|
Dossier |
Basic | Analytical Procedure | Stability Data | Complete |
| Price | free of charge | EUR 3,400 | EUR 5,850 | EUR 7,500 |
| Agreement | No | Yes | Yes | Yes |
| Update | Every 3 months | No | Yes1) | Yes2) |
1) maximally until the stability study is completed
2) every twelve (12) months for five (5) years after signing of the Agreement
For more information, please contact us.
