In order to bring a new pharmaceutical product to the market in the EU, a marketing authorisation application (MAA) must be granted by the European Commission after evaluation by the European Medicines Agency.
A requirement for the MAA, is to demonstrate that the product will not cause harm in the environment. Our specialist team of environmental fate scientists and ecotoxicologists are perfectly placed to perform Environmental Risk Assessments (ERAs), including refined ERA, for human medicinal products. We have experience in assessing a range of product types.
Our services include:
- Regulatory advice and support
- PBT assessments
- Calculation of PECSW for Phase I ERA
- Refinement of market penetration factor (Fpen)
- Tailored RA for Endocrine Active Substances and antibiotics
- Data gap analysis
- Literature search & reliability assessments
- Study placement, monitoring, and evaluation
- Tier A Phase II and Tier B (refined) ERA
- Labelling and risk mitigation recommendations
For further information explore our Service Information Sheet.