Environmental risk assessment (ERA)
Environmental Risk Assessment (ERA) is a mandatory requirement for EMA submissions and global regulatory approvals. Companies often struggle to coordinate regulatory strategy, PEC calculations, Phase II testing, and PBT assessment across multiple partners.
We offer a true one-stop solution, combining regulatory ERA consulting with in-house ecotoxicology, biodegradability, and analytical testing capabilities.
Coordinated management of environmental studies, analytical support, ecotoxicology testing, and regulatory documentation within a single framework.
Tailored testing strategy
Definition of a risk-based ERA testing strategy integrating Phase I screening, Phase II study planning, and alignment with EMA guidelines. Testing activities can be directly coordinated within the Eurofins laboratory network.
Gap analysis
Comprehensive review of available environmental data to identify missing endpoints, optimise testing requirements, and reduce unnecessary studies through scientifically justified waivers.
PBT/vPvB assessment
Regulatory evaluation of PBT and very Persistent, very Bioaccumulative (vPvB) criteria supported by laboratory data and scientific interpretation.
Regulatory Communication & Data Access Strategy
We support companies in liaising with competent authorities, managing communications on their behalf, also assisting in obtaining Letters of Access (LoA) from original Marketing Authorisation Holder (MAH), when applicable.