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Emprove® Program > Emprove® Chemicals > Emprove® Dossiers for Chemicals
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Emprove® Dossiers for Chemicals

Satisfy Your Regulatory Requirements

 

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

Emprove - Material Qualification Dossier

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*

Emprove - Quality Management Dossier

Quality Management Dossier

Answers questions during quality risk assessment according to ICH Q9 and EU 2015/C95/02.

Demo Dossier

  • Supply chain information
  • Product quality self-assessment**
  • Audit report summary

Free of charge*

Emprove - Operational Excellence Dossier

Operational Excellence Dossier

Supports process optimization and safety risk assessment activities.

Demo Dossier

  • 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

Demo Information Package

  • 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.

Learn more about our Emprove® Filters and Single-use Component Portfolios and Dossiers

Emprove® Suite Subscription

Unlock Full Access to all dossiers today with the Emprove® Suite Subscription.

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  • One-time registration
  • 24/7 full online access
  • Subscription period 1 or 2-year subscriptions