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Evaluation of the environmental risks of medicinal products (free guideline)

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Why are Environmental Risk Assessments necessary? What evaluation phases and methods do exist? Learn all the basic information about ERAs in this free guideline!

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Why do you need an environmental risk assessment?

Nowadays the application for the putting a medicinal product for human use on the market requires an environmental risk assessment report. This report must be based on the instructions of the EMA's Guideline on the Environmental Risk Evaluation of Medicinal Products for Human Use (Doc. Ref. EMEA/CHMP/SWP/4447/00 corr. 2).

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.

You get with us reports for the analysis and assessment of possible environmental risks of an API.

Evaluation procedures are based on the current EU guide: EMEA/CHMP/SWP/4447/00 corr 2.
- Phase I: Estimation of exposure
- Phase II: Environmental fate and effects analysis
Risk Assessment for each API using the latest version of the IQVIA data base.
Specialised environmental toxicologists with wide experience in new drug registrations.

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

Company name and address
Name of the medicinal product
Name of the country in which the product is to be sold
Maximum daily dose

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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-publishing.com

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

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Format:

This download is a PDF file with a file size of 11,96 MB.
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