Enabling science. Ensuring compliance. Safeguarding ecosystems.

Eurofins Agroscience Services supports human and veterinary medicinal product developers with end-to-end ERA programmes that meet the latest EMA requirements and global expectations.

Our approach combines deep substance understanding, advanced analytics, and efficient GLP execution, from analytical characterisation and radiolabelled fate to OECD ecotox batteries and EMA Module 1.6 reporting.

We deliver clear, defensible science to keep your development on track and your dossiers compliant — efficiently and sustainably.

What we do

We design and execute Phase I → Phase II ERA programmes per EMA guideline, covering PEC assessment, environmental fate, ecotoxicology, and risk mitigation as required for new MAAs, for variations / extensions as well as for Generics & Legacy APIs.

We align study designs with EMA’s tiered decision tree (Phase I PECsw threshold and tailored routes for endocrineactive substances, antibiotics, secondary poisoning) to ensure relevance and 3R principles.

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Study designs built on substance knowledge

Before designing any study, we thoroughly explore the substance profile with analytical fingerprinting, impurity/metabolite mapping, and mode of action. This early analytical deep‑dive ensures fit-for-purpose, efficient, and scientifically justified study programmes — reducing avoidable testing and improving.

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High-end analytical excellence

We offer unrivalled capabilities for quantification, impurity profiling, metabolite identification, radiolabel tracking, and structure elucidation.

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ERA optimised ecotox and eFate

We run OECD/ISO/EPA‑aligned studies on algae, daphnia, fish, soil organisms, biodegradability etc, tailored to EMA’s tiered triggers and refinement steps, compliant with Good Laboratory Practices (GLP).

Visit our global site to explore our capabilities:

Product and analytical chemistry
Radiolabelling and synthesis
Environmental safety
Regulatory consultancy