De-Risking Pharma Pipelines: An Integrated Approach to Environmental Risk Assessments (ERA)
When assessing a new Active Pharmaceutical Ingredient (API) for human medicines, calculating the Predicted Environmental Concentration in Surface Water (PECSW) is a critical milestone. If the PECSW value exceeds regulatory threshold at Phase I (0.01 µg/L), or if you are working with an API with a specific mode of action like antibacterials, your project must immediately pivot from Phase I paper-based risk assessment to Phase II Tier A that requires laboratory testing.
Managing that transition without losing momentum is where many pipelines stall.
At Staphyt, we bridge the gap by uniting regulatory intelligence and in-house GLP laboratory execution under one roof, delivering an end-to-end ERA roadmap that strictly meets European Medicines Agency (EMA) requirements.
Here is how we streamline the science and the strategy:
📋 Phase I – Environmental Risk Assessment: Our regulatory experts handle comprehensive data intelligence, accurate exposure estimation (PECSW), and strict EMA compliance verification.
🔬 Phase II Tier A and B – Environmental Risk Assessment & GLP Data Generation: When triggered, our regulatory experts conduct the ERA for Phase II Tier A (and B if needed), and our in-house facility seamlessly generates the tests officially required for the estimation of the risk . We cover tests from Phys-Chem and E-Fate characterization (OECD 105, 106, 107/123, 301) to comprehensive ecotoxicological assays spanning aquatic (the three trophic levels and all possible test designs: static, semi-static and flow-through), sediment, soil, and activated sludge from Sewage Treated Plants (STP).
🧪 Custom Analytical Validation: We develop and validate analytical methods tailored to your specific API across water, sediment, and complex test media.
By keeping both the regulatory strategy and the laboratory execution in-house, we eliminate friction and accelerate your compliance journey.
Are you interested? Contact us at: contact@staphyt.com
