Elemental Impurities Risk Assessment - Sample Document

Are you not quite sure what an elemental impurities risk assessment looks like and would like to take a look inside? Get your free sample document now!

Why do you need an elemental impurities risk assessment?

As of June 2016, all new medicinal products have to be evaluated based on the ICH guideline Q3D on elemental impurities. As of December 2017, this guideline came into effect for already authorised medicinal products as well. Therefore, every authorised medicinal product has to be evaluated.
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How to obtain an elemental impurities risk assessment?

The proven and successful collaboration between Azierta and GMP-Verlag Peither AG provides you with an economically priced alternative to conventional elemental impurities risk assessments. Following verification of the critical key data, we will be pleased to send you a binding, fixed price quote.

Our service includes:
Issuing of the elemental impurities risk assessment

• according to ICH Q3D guideline in English
• issued for the specific medicinal product according to ICH Q3D guideline
• issued by European toxicological experts

This is what we need from you to prepare a binding, fixed price quote

• Company name and address
• Name of the medicinal product
• Completed questionnaire

Questions?

If you have questions or would like to request a quote, please contact:

Cynthia Schulz
Phone: +49 7622 6668670
E-Mail: cynthia.schulz@gmp-verlag.de

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