Environmental Risk Assessment

Marketing authorization applications require an Environmental Risk Assessment evaluating the potential environmental impact of a medicinal product, and an inadequate ERA is a recurring source of deficiency questions. PharmExpert prepares ERAs that meet EMA and other agency expectations and integrate cleanly into your dossier.

The assessment is phased. Phase I estimates environmental exposure (the predicted environmental concentration); only where a trigger is exceeded does a Phase II evaluation of environmental fate and effects become necessary. We scope the work accordingly, so effort is proportionate to the actual risk.

We perform the calculations and, where required, the fate-and-effects evaluation, drawing on the relevant data and literature, and author the ERA report and any tailoring or justification arguments for the dossier.

Where agencies raise ERA-related questions, we author the justifications and responses to resolve them. The result is a defensible ERA that satisfies the requirement without becoming a bottleneck in your submission.