Emprove® Program
Introducing a new drug to the market is an extensive and intricate process. Development, testing, and registrations take years to complete, yet you must be ready for quick market launch by expediting approvals and maintaining reliable manufacturing processes at every step. Now you can confidently speed your way through the regulatory maze and fast track your new drug to market, with the Emprove® Program.
The Emprove® Program combines high-quality products, comprehensive documentation, and superior customer support to facilitate your efforts in qualification, risk assessment, and process optimization. Choose from over 2000 dossiers covering hundreds of raw and starting materials, filter and single-use products, chromatography resins, and cell culture media. These are the Emprove® product portfolios:
Speed your way through the regulatory maze
The Emprove® Program provides full supplier transparency at your fingertips, anticipating industry expectations not yet covered by regulation. Each product portfolio is supporting different steps in your qualification process:
- Material Qualification Dossier
- Quality Management Dossier
- Operational Excellence Dossier
This combination of high-quality products and comprehensive, up-to-date documentation sets our Emprove® Program apart – helping you to navigate regulatory challenges, manage risks, and improve your manufacturing processes.
Emprove® Suite: 24/7 online access to all our dossiers
Getting the information you need is even more convenient when you subscribe to our Emprove® Suite. Subscribers receive online access to all dossiers of the entire Emprove® portfolio, in a format that is constantly updated and optimized for targeted search. Key features include:
- Subscriptions of one and two years
- Notification option to let you know when new dossier updates are available
- Material Qualification Dossier available free of charge via our website for specific product detail pages, or as a downloadable document
Related Product Resources
White Paper: Identifying Appropriate-quality Raw Materials in an Evolving Regulatory Environment
White Paper: The Role of BPOG Extractables Data in the Effective Adoption of Single-use Systems
Risk Mitigation Tool: Support for Biomanufacturing Processes
White Paper: A practical approach for determining extractables in chromatography resins in the light of the upcoming USP chapter
Article: Aiding Material Qualification and Risk Assessment for Single-Use Biomanufacturing
Article: Championing In Vitro Biocompatibility/Biological Reactivity Testing for Plastics Used in Pharma Manufacturing
Related Webinars
How Standardized Extractables Data Support E&L Risk Assessment
Adapted Approach of Upcoming USP <665>
Nitrosamines– New Requirements to Evaluate Contamination Risks
The Emprove® Program – An Introduction Focusing on the Emprove® Suite and Emprove® Chemicals content
Risk-Based Approach to Evaluate Nitrosamines and Elemental Impurities from Single-Use Component
Is USP <88>, Class VI Animal Bioreactivity Testing necessary for Plastics used in Manufacturing?
Regulatory Talks: Finalization of USP <665>
Risk-Based Qualification of X-Ray Sterilization for Single-Use Systems
The Future of Pharma- and Biopharmaceutical Audits
Regulatory Considerations Including Extractables & Leachables for Single-Use Manufacturing
Related Videos
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