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Emprove® Chemicals Portfolio

For drug manufacturers striving to simplify raw material selection while satisfying regulatory requirements, our Emprove® Chemicals portfolio contains over 400 pharmaceutical raw materials organized by different levels of risk.

All raw and starting materials are organized into categories to streamline selection, with each product offering the comprehensive, up-to-date documentation you need to navigate regulatory challenges, manage risks, and improve processes.

The portfolio is divided into four categories:

  • Emprove® Evolve is for early stages of biopharmaceutical manufacturing, bridging the gap between lab-grade and GMP compliant raw and starting materials while providing transparent supply chain information and documentation.
  • Emprove® Essential is for moderate-risk applications, offering compliance to IPEC-PQG GMP Guide and/or EXCiPACT™ Certification Standard, as well as supply chain transparency and regulatory support designed to assist drug manufacturers’ formalized risk assessments.
  • Emprove® Expert is for higher-risk applications where the lowest microbiological and endotoxin levels are of utmost importance. Along with the risk management features of Emprove® Essential, the Emprove® Expert line yields products with specified low microbiological and endotoxin levels, supporting the overall risk mitigation strategy.
  • Emprove® API is for final drug product compliance with international standards, manufactured in Europe to meet the quality and regulatory requirements of active pharmaceutical ingredients (API) according to ICH Q7 GMP. Dedicated support by our regulatory management team includes access to extensive documentation, such as DMFs, CEP, and ASMF.

Supporting Technical Content

Documentation to speed your way through the regulatory maze

As part of the Emprove® Program, the complete Emprove® Evolve, Essential, and Expert chemicals portfolio is supported by Emprove® Dossiers. This comprehensive documentation facilitates your qualification, risk assessment, and process optimization efforts.

Emprove® Dossier Library for Raw and Starting Materials

In addition, Emprove® API products can include a letter of authorization (LOA, also known as letter of access or CEP access), granting the right to incorporate the DMF, ASMF, or CEP dossier by reference in the drug product application. Elemental Impurity Reports can also be obtained as part of the Emprove® Suite.

Quality and service transparency

We support our partners in their risk assessment efforts by providing detailed information about the applied Quality Management system, the supply chain, extractables data, and data on the stability of a product. To learn more, select any of the criteria below for our Quality & Service Catalog.

Emprove® Raw and Starting Materials by Category

Emprove® Suite: 24/7 online access to all our dossiers

Unlock all the benefits of the Emprove® Chemicals portfolio by subscribing to our Emprove® Suite. Available exclusively for subscribers, all dossiers of the entire Emprove® portfolio can be accessed at your convenience.

  • Subscriptions of one, two, or five years
  • 24/7 online access
  • Constantly updated
  • Optimized searches

To subscribe today, simply complete and submit the reply form below after reading our Emprove® terms and conditions.

Keeping up with evolving regulations of raw materials

Critical raw materials currently have no clearly defined regulatory standards or quality requirements, but are coming more and more into regulatory focus. We continue to advance our Emprove® Chemicals portfolio with the recent addition of the Emprove® Evolve product line, providing fit-for-purpose high-quality raw materials for early stage manufacturing applications. As developing regulatory requirements for critical raw materials pose new challenges, we will continue to evolve our offerings to support your quality risk assessment with detailed documentation and supply chain transparency and control.

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Related Videos

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  • Emprove® Dossiers provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.
  • Each product portfolio is supported with Emprove® Dossiers which provide comprehensive, up-to-date documentation to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes.