Der Artikel wurde erfolgreich hinzugefügt.

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

Enter the first customer review for this item

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

Delivery immediately after receipt of payment

€0.00 net

€0.00 * prices incl. VAT

X

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 Maas & Peither 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.

>>> Read more about environmental risk assessments


Customer reviews will be activated after verification.
Write a customer review

Please enter these characters in the following text field.

The fields marked with * are required.

After ordering you will receive a download link by e-mail within 1-2 working days.

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/

€259.00 net

€210.00 net

  • Elemental Impurities Risk Assessment - Sample Document
    Download

    Are you not quite sure what an elemental impurities risk...

    €0.00 net

  • How to implement ICH Q3D of elemental impurities in 5 steps (free manual)
    Download

    Do you already know how to proceed after having obtained an...

    €0.00 net

  • OEL Categorisation - Sample Document
    Download

    Are you not quite sure what an OEL categorisation looks like and would like to take a look...

    €0.00 net

  • PDE Report - Sample Document
    Download

    Are you not quite sure what a PDE report looks like and would like to take a look inside? Get...

    €0.00 net

  • GMP LOGFILE

    Newsletter

    With this GMP newsletter you will be regularly informed on the latest developments in GMP.

    Sign up