Der Artikel wurde erfolgreich hinzugefügt.

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

Geben Sie die erste Bewertung für diesen Artikel ab

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

PDF-Download

Lieferung sofort nach Zahlungseingang

0,00 € netto

0,00 € * inkl. gesetzlicher MwSt.

Beschreibung

Bewertungen

Techn. Voraussetzungen

Zurück zum GMP-Shop

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

Request your quote now!

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.

Zurück zum GMP-Shop

Bewertungen können anonym erfolgen und werden nach Überprüfung in unserem Webshop veröffentlicht.

Zurück zum GMP-Shop

Format:

This download is a PDF file with a file size of 11,96 MB.
You will need Adobe Reader to open this file:
https://get.adobe.com/de/reader/

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.