- The Emprove® Program
- Chemicals
- Filters & Single-use
- Chromatography
- Cell Culture Media
- Emprove® Suite Subscription
Three Levels of Information Supporting Quality Risk Assessment and Regulatory Requirements
To address evolving regulatory requirements, we are constantly developing our Emprove® Dossier library to better meet your regulatory challenges.
The information on each of our Emprove® Evolve, Emprove® Essential and Emprove® Expert products facilitates your raw material qualification, risk assessment and process optimization efforts.
Emprove® Dossiers in Detail
Emprove® Dossier Library for Raw and Starting Materials
Material Qualification Dossier
Supports raw material qualification and speeds up drug filing preparation.
In line with CTD chapter 3 quality (adapted for excipients)
- General information
- Manufacturer
- Characterization (incl. regulatory declarations: BSE/TSE, melamine, nitrosamine, etc.)
- Control of drug substance
- Reference standard
- Materials
- Container closure system
- Stability summary
Free of charge*
Quality Management Dossier
Answers questions during quality risk assessment according to ICH Q9 and EU 2015/C95/02.
- Supply chain information
- Product quality self-assessment**
- Audit report summary
Free of charge*
Operational Excellence Dossier
Supports process optimization and safety risk assessment activities.
- Elemental impurities information
- Product quality report
- Analytical procedure
- Technically Unavoidable Particle Profile (if applicable)
- Stability data***
Premium*
Emprove® API Information Package
Supports Emprove®API qualification and risk assessment
- General Information
- Manufacture
- Specification
- Regulatory Certificates
- Product Quality Self Assessment
- Packaging Information
- Stability Summary and Conclusion
Free of charge
* The Material Qualification Dossier and the Quality Management Dossier are free of charge and available on the specific product detail pages of our website after log-in. It can also be downloaded through the Emprove® Suite.
*The Operational Excellence Dossier can be purchased individually on the product detail pages of our website after log-in or unlimited access through our Emprove® Suite Subscription.
** Based on Rx-360 SAQ Module 3
*** Available for Emprove® Essential and Emprove® Expert products only, based on long-term stability studies according ICH Q1A requirements.
Emprove® Suite Subscription
Unlock Full Access to all dossiers today with the Emprove® Suite Subscription.
Subscribe- One-time registration
- 24/7 full online access
- Subscription period 1 or 2-year subscriptions