Environmental Risk Assessment is a part of the medicinal product’s dossier and is intended to describe the environmental safety profile of the medicinal products. It is required for all new marketing authorization applications, for type II variations or in case there is an increase in environmental exposure.

Biomapas can connect you with the right experts who could support you in preparing Environmental Risk Assessment Report that is suitable for your product. Also, our medical writers can make sure that your Environmental Risk Assessment Report adheres to all relevant guidelines, is technically sound and well-written.