Evaluation of the environmental risks of medicinal products (free guideline)
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?
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
Questions?If you have questions or would like to request a quote, please contact:
Phone: +49 7622 6668670
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