Enabling science. Ensuring compliance. Safeguarding ecosystems.
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.
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.
We offer unrivalled capabilities for quantification, impurity profiling, metabolite identification, radiolabel tracking, and structure elucidation.
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).
