Emprove^® Suite

THE NEW EMPROVE^® SUITE: THE RIGHT DOSSIERS AT THE RIGHT TIME.

The mission of the Emprove^® Program is to leverage our regulatory intelligence and our participation in industry consortia to proactively develop, obtain and compile the information you need into Emprove^® Dossiers that support you in the selection, qualification, and approval of raw materials - both initially and periodically. To streamline your supplier quality risk management processes, we are offering the new Emprove^® Suite. This platform provides convenient and comprehensive access to a broad portfolio of Emprove^® Dossiers. You can easily search, find, view and download free and subscription-based dossiers dependent upon your subscription option. You can also find the new Emprove^® Advanced Qualification Dossier for Mobius^® “Custom” Assemblies in the Platinum subscription.

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• Go to Emprove^® Suite log-in

• Learn more about the Emprove^® Program

ONE POWERFUL PLATFORM FOR ALL EMPROVE^® DOSSIERS.

The Emprove^® Suite consolidates the Emprove^® Dossiers into a single platform and makes them readily available to be securely accessed by any employee in your company - anytime from anywhere in the world. Thanks to enhanced search functions, you can easily find Emprove^® Dossiers, and view and download them as needed. All activities are displayed on an individualized dashboard, enabling quicker access to frequently used dossiers.

The new Emprove^® Suite makes it easier for you to qualify a material, perform a risk assessment, conduct a patient safety evaluation and satisfy a request from a regulatory authority. In short, you will find the exactly the dossiers you need to support your drug manufacturing process:

• Material Qualification Dossiers (MQDs)

• Quality Management Dossier (QMDs)

• Operational Excellence Dossier (OEDs)

• NEW Advanced Qualification Dossiers (AQDs)

FEATURES OF THE NEW EMPROVE^® SUITE:

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THE DOCUMENTS HOSTED ON THE EMPROVE^® SUITE.

We offer different Emprove^® Dossiers and information packages, depending upon the portfolio of products in which you are interested and your risk assessment needs. The information has been compiled in line with the ICH Common Technical Document Chapter 3 quality.

• API Information Package: Provides necessary product quality information for initial evaluation of the Active Pharmaceutial Ingredient with regards to all kinds of applications.*

  * Disclaimer: This information package is not intended to be used as official documentation for registration by the authority. The registration procedure for active pharmaceutical ingredients in final drugs is strictly regulated. The CEP and DMF/ASMF procedures enable API manufacturers to protect their intellectual property. Access to CEPs and LoAs for US DMFs (and other DMFs) and ASMF applications can be provided on request to support drug applications using our Emprove^® API.

• Elemental Impurities Information (for API’s): Elemental Impurities Information (for API’s) – provides the elemental impurities that may be present to assist in your risk assessment per ICH Q9

• Material Qualification Dossier (MQD): Contains information to support the qualification of the raw material and/or component for use in (bio)pharmaceutical manufacturing.

• Quality Management Dossier (QMD): Contains extended information to support risk assessment activities and to qualify us as a supplier according to ICH Q9 and EU 2015/C95/02 as they relate to (bio)pharmaceutical manufacturing.

• Operational Excellence Dossier (OED): Contains information to reduce material testing and support process optimization and continuous improvement for (bio)pharmaceutical manufacturing.

• NEW! Advanced Qualification Dossier (AQD): Contains information for custom products to support their qualification for use in (bio)pharmaceutical manufacturing and their evaluation of patient safety for the go-to-market phase. (Coming Soon! for Mobius^® Single-Use Assemblies in Q1 2023). Click here to learn more about the AQD.

You can find more information about the dossiers on the respective Emprove^® Portfolio pages.

THE SUBSCRIPTION MODELS.

With our Emprove^® Suite, you can select the subscription option that best meets your needs: Prime, Premium, and Platinum. In addition, you can upgrade your subscription to a higher level anytime. All subscription options provide an unlimited number of users within a company with access to specific Emprove^® Dossiers with enhanced search features, opt-in notification updates, and activity dashboards?

Discover Emprove^® Suite

Prime

• Free subscription without a time limit

• Unlimited access to API Information Packages, Material Qualification and Quality Management Dossiers

• Ability to purchase Premium (Elemental Impurities Information, Operational Excellence Dossiers), as well as Platinum (3rd Party Extractables Reports and Advanced Qualification Dossiers individually) subscription

Premium

• Subscription for 1 or 2 years

• Unlimited access to API Information Packages, Elemental Impurities Information, Material Qualification, Quality Management and Operational Excellence Dossiers

• Ability to purchase Platinum (3rd Party Extractables Reports and Advanced Qualification Dossiers individually) subscription

Platinum

• Subscription for 1 or 2 year

• Unlimited access to API Information Packages, Elemental Impurities Information, Material Qualification, Quality Management and Operational Excellence Dossiers, 3rd Party Extractables Reports and Advanced Qualification Dossiers*

  * No need to purchase any dossiers individually

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*UNLIMITED within purchased timeframe