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.
2,000.00 EUR net for one substance in one country
130.00 EUR net for each additional country
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.