Environmental Risk Assessment (ERA)

Environmental Risk Assessment (ERA) is a core regulatory requirement for pharmaceutical products, forming an essential part of the marketing authorization dossier in the EU and other jurisdictions.

ERA evaluates the potential environmental impact of an active pharmaceutical ingredient (API) and its lifecycle, helping sponsors demonstrate that environmental exposure is understood, quantified, and controlled.

Given increasing regulatory expectations for environmental protection, a well-prepared ERA report is a cornerstone of dossier completeness and supports both regulatory compliance and inspection readiness

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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 environmentalexposure 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.

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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 to deliver submission-ready documentation.

Our support includes:

Comprehensive data gathering and technical assessment, covering usage data, physicochemical properties, environmental fate, and ecotoxicology.
Exposure and risk evaluation, including PEC calculation and refinement, PNEC derivation, and PBT/vPvB screening where relevant.
Scientific justification of testing strategies, 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 current regulatory expectations.

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.

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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.

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Why QbD Group?

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.

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End-to-end toxicology support

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10+ years of experience

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Compliance monitoring

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Certified toxicology experts

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Have questions about our environmental risk assessment services or need certified ecotoxicology reports?

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