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.
Supports raw material qualification and speeds up drug filing preparation.
In line with CTD chapter 3 quality (adapted for excipients)
Free of charge*
Answers questions during quality risk assessment according to ICH Q9 and EU 2015/C95/02.
Supports process optimization and safety risk assessment activities.
Supports Emprove®API qualification and risk assessment
Free of charge
* The Material Qualification Dossier is 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.
** 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.
Unlock Full Access to all dossiers today with the Emprove® Suite Subscription.Subscribe