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.
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.
- 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 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!
Pricing:
2,000.00 EUR net for one substance in one country
130.00 EUR net for each additional country
Why can we offer toxicological reports for such a competitive price?
Our partner Azierta is the market leader in Spain for the preparation of toxicological assessments and employs approximately 15 toxicologists for the preparation of assessments. These are also successfully used by the industry in other European countries (e.g. Germany, Switzerland, Italy, Belgium) and have been accepted by the authorities.