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How to implement ICH Q3D of elemental impurities in 5 steps (free manual)

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Do you already know how to proceed after having obtained an Elemental impurities risk assessment? Our download "How to implement ICH Q3D of elemental impurities in 5 steps" shows you how to successfully achieve marketing authorization for your medicinal product - for free!

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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

or fill in the above questionnaire and return it to us.

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This file is in PDF format!

Filesize: 8.5 MB

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The download is password protected to prevent copying and modification of content.

Please note the following procedure guidelines:

For payment by invoice:

You will receive an advance invoice by e-mail within 1-2 working days. You payment is required for the download.
After receipt of payment you will receive an e-mail with the download information.

When paying by credit card:

Immediately after the credit card payment you will receive an email with the download information.
Your invoice will be sent in a separate e-mail within 1-2 working days.