As of September 1, 2024, the updated Environmental Risk Assessment (ERA) guidance introduces a comprehensive framework for evaluating the environmental risks associated with medicinal products for human use.
At ToxMinds, we are here to help you navigate these changes effectively.
Our services include the preparation of EMA-compliant submissions in line with EMEA/CHMP guidelines, ensuring that your products meet the latest regulatory standards. We conduct thorough literature reviews on endpoints significant to ERA, uncovering new information on the ecotoxicity of active substances.
We evaluate the relevance and reliability of ecotoxicity and eco-fate data using CRED criteria, providing you with a robust assessment of your substances’ intrinsic properties, including PBT and endocrine disruption potential. Our team develops tailored ecotoxicology and ecological fate testing strategies to suit your specific needs.
Additionally, we assist in securing contract research organizations and monitoring study performance to ensure quality outcomes. We also liaise with competent authorities, responding to comments and questions throughout the registration process.
With over a decade of experience in the pharmaceutical sector, ToxMinds is dedicated to providing expert guidance and support, ensuring your products comply with the latest ERA standards while promoting environmental sustainability.