Environmental Risk Assessment (ERA)
Mandatory ERA reports aligned with EMA regulatory expectations
QbD Group supports pharmaceutical companies throughout the full ERA lifecycle, combining scientific expertise with a practical, risk-based approach to deliver submission-ready documentation for Marketing Authorization Applications.
The role of Environmental Risk Assessment in Marketing Authorization
Environmental Risk Assessments are not optional add-ons; they are a mandatory requirement in many regions, especially for new Marketing Authorization Applications (MAAs) where environmental exposure may change.
An ERA helps regulators assess the likelihood of harm to aquatic and terrestrial ecosystems based on predicted environmental concentrations and ecotoxicological data.
When completed correctly, ERA reports provide transparent justification for exposure estimates and test decisions, help avoid unnecessary studies, and facilitate smoother regulatory interactions. Consolidating data from literature, fate studies, and refined exposure assessments into a coherent submission-ready document is key to meeting regulatory expectations and avoiding delays.
How QbD Group supports your Environmental Risk Assessment
Structured, science-driven ERA support aligned with regulatory expectations. We support pharmaceutical companies throughout the full ERA lifecycle, combining scientific expertise with a practical, risk-based approach.
Comprehensive data gathering
Covering usage data, physicochemical properties, environmental fate, and ecotoxicology.
Exposure and risk evaluation
PEC calculation and refinement, PNEC derivation, and PBT/vPvB screening.
Scientific justification
Supporting targeted assessments, test waivers, or refinements in line with EMA guidance.
Clear, structured ERA reports
Designed for direct inclusion in CTD Module 1.6 and aligned with regulatory expectations.
Our process
We follow a stepwise, science-driven approach aligned with EMA guidance to deliver submission-ready ERA reports.
1. Early scoping
Align on API, target markets, indication, and available data.
2. Data gathering
Comprehensive technical assessment of usage, physicochemical, fate, and ecotoxicological data.
3. Exposure assessment
PEC calculations, refinements, and PNEC derivation.
4. Report preparation
Submission-ready ERA report for CTD Module 1.6.
From early scoping to submission-ready ERA reports
Value delivered to our clients
Regulatory confidence
ERA reports structured in line with EMA guidance, supporting smooth dossier review and acceptance.
Reduced unnecessary testing
Strategic use of existing data, refinements, and scientific justification to avoid irrelevant studies.
Efficiency and predictability
Clear workflows and early risk identification help prevent late-stage surprises and delays.
Inspection-ready documentation
Transparent calculations, full referencing, and traceable decision-making aligned with regulatory scrutiny.
Why QbD Group
Your trusted partner
Our EUROTOX-certified team delivers efficient, science-driven ERA support aligned with regulatory expectations.
End-to-end toxicology support
from early development to post-approval changes, we provide integrated risk assessments seamlessly aligned with QA, CMC, and regulatory strategies.
Trusted expertise at scale
with decades of combined experience across diverse projects and markets, our toxicology team provides reliable insights that add efficiency, consistency, and confidence to every assessment.
Proactive compliance monitoring
through strict oversight of reports, we help clients stay in full control of toxicology obligations, proactively alerting them to potential non-conformities before they become risks.
Certified Toxicology Experts
our reports are prepared and reviewed by EUROTOX-certified (ERT) toxicologists, ensuring the highest standards of scientific quality, regulatory reliability, and patient safety across every assessment.
Let's talk Toxicology
From risk assessments to regulatory compliance, our toxicology experts are ready to support your pharmaceutical needs.