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.
Cynthia Schulz
Phone: +49 7622 6668670
E-Mail: cynthia.schulz@gmp-verlag.de
Sample documents: