Evaluation of the environmental risks of medicinal products (free guideline)
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E-book
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 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
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