TEST Evaluation of the environmental risks of medicinal products (kostenlose Guideline) Kopie

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Why Do You Need an Environmental Risk Assessment?

Nowadays, the application for placing 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.

What You Get With Us

We provide comprehensive reports for the analysis and assessment of possible environmental risks of an API:

Evaluation procedures based on the current EU guideline: 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 database.
Specialised environmental toxicologists with extensive experience in new drug registrations.

Information Required for a Fixed Price Quote

To prepare a binding, fixed price quote, please provide the following information:

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

Do you Have any Questions?

Cynthia Schulz, Vertrieb und Key Account für Toxkologische Gutachten beim GMP-Verlag

Talk to our customer advisors

Do you have any questions about our products and services? We are here to help.

Cynthia Schulz

cynthia.schulz@gmp-verlag.de +49 (0)7622 66686-70

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