---
title: "Environmental Risk Assessment (ERA) — Toxicology Services | QbD Group"
description: "QbD Group supports pharmaceutical companies throughout the full ERA lifecycle, combining scientific expertise with a practical, risk-based approach to deli"
url: https://qbdgroup.com/en/services/toxicology/environmental-risk-assessment-era
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"Environmental Risk Assessment (ERA) — Toxicology Services | QbD Group\", https://qbdgroup.com/en/services/toxicology/environmental-risk-assessment-era"
---

# 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

We begin with early scoping to align on the API, target markets, indication, and available data, **ensuring the ERA strategy fits the regulatory context from the start**.

Our team applies a **stepwise approach**: initial Tier A PEC calculations, refinement using country-specific prevalence and consumption data, and integration of literature and historical data to support scientifically robust conclusions. Where appropriate, we prepare **clear justifications for waiving non-relevant studies** or avoiding escalation to higher assessment tiers.

Each project concludes with a **submission-ready ERA report**, fully traceable, transparently documented, and prepared to withstand regulatory review.

## 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.

Contact us

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Source: https://qbdgroup.com/en/services/toxicology/environmental-risk-assessment-era — © QbD Group. Quote freely with attribution and a link back.