Environmental Risk Assessment (ERA)

An Environmental Risk Assessment (ERA) report is mandatory for every application
for a new marketing authorisation for a medicine for human use.

Request a quote

ERA refers to risks related to the use, storage, and disposal of medicinal products and not to any risks resulting from the synthesis or manufacture of these products.

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.

Carried out by specialised environmental toxicologists with wide experience in new drug registrations.

More than 50 reports carried out in Europe during the last year.

This is what we need from you to prepare a quote:

Name and address of the company
Name of the medicinal product
Name of the country in which the product is to be sold
Maximum daily dose

Request for Offer: Toxicological Assessments

Request a non-binding offer for one or more of our toxicological reports now.

Please inform yourself about the processing of your personal data in our Data Privacy Statement before sending the contact form.

Type of assessment *

PDE Report

OEL Report

Elemental Impurities Risk Assessment

Organic Impurities

Mutagenic Impurities

Environmental Risk Assessment (ERA)

API / Product / Contamination *

Dosage form *

Application way *

Comments, questions, suggestions

Prefix

First Name *

Last Name *

Company *

Street *

Postcode, City *

Country *

E-Mail *

Phone *

Fields marked with asterisks (*) are required.

Privacy*

By selecting continue you confirm that you have read and agree to our data protection information.

Do you have any Questions?

Talk to our customer advisors

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

Cynthia Schulz

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

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

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 QuoteTo 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

Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)

€0.00 net excl. VAT

Details