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 Rev. 1- Corr.
- 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.
- 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
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