Emprove® Chemicals Portfolio:
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Designed for moderate risk applications, Emprove® Essential products offer GMP compendial compliance, supply chain transparency and regulatory support designed to assist drug manufacturers‘ formalized risk assessments. They are produced according to controlled manufacturing processes. Critical parameters such as elemental impurities and residual solvents are characterized by using validated analytical techniques.
Addresses 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 goes even further: The cGMP manufacturing processes are designed to yield products with specified low microbiological and endotoxin levels, thus supporting the overall risk mitigation strategy.
Manufactured in Europe to meet the quality and regulatory requirements of active pharmaceutical ingredients, according to ICH Q7 GMP. In order to support final drug product compliance with international standards, our Regulatory Affairs team offers dedicated support with access to extensive documentation including DMFs, CEP and ASMF.
The information on each of the Emprove® Essential and Emprove® Expert products is organized into three types of dossiers that help to facilitate your qualification, risk assessment and process optimization efforts. For Emprove® API products, we offer LoA (letter of authorization, letter of access, CEP access) to provide the right to incorporate the DMF, ASMF or CEP dossier by reference in the drug product application. In addition, Elemental Impurity Reports can be obtained as single documents as part of the Emprove® Suite.
|Grade||Material Qualification Dossier 1||Quality Management Dossier||Operational Excellence|
|DMF, ASMF, CEP|