ADME (Absorption, distribution, metabolism and excretion)

This service provides comprehensive absorption, distribution, metabolism, and excretion (ADME) studies to support the non-clinical development of healthcare products, including advanced therapies and chemical-based innovations. It encompasses both in vitro and in vivo ADME assessments, pharmacokinetic profiling, and toxicokinetic evaluations, alongside tailored advisory support to define an appropriate development roadmap aligned with the product profile and regulatory requirements. The service is designed for EIC beneficiaries, including public research organisations (universities and research institutes) and private sector entities (biotechnology and pharmaceutical companies) developing health-related products such as ATMPs or chemicals. Its primary objective is to characterise the ADME profile of a substance, providing a detailed understanding of its physiological pathway, biotransformation, and elimination within the organism. The duration of the service depends on the study design, expected residence time of the compound, and analytical methods employed, typically ranging from a few weeks to several months. The engagement begins with a protocol development phase, during which the study design is defined in close collaboration with the beneficiary. This is followed by study execution, data analysis, and the preparation of a comprehensive final report. For GLP studies, all phases, including protocolisation, execution, analysis, and reporting, are conducted under strict quality control and audited in compliance with GLP requirements. All studies are performed under ISO 9001:2015-certified quality management systems, with GLP compliance applied where required. The service is delivered by in-house scientific teams, supported by internal auditors and regulatory experts to ensure high-quality outputs and adherence to international standards. As a result, beneficiaries receive a robust and comprehensive final study report suitable for internal decision-making and/or regulatory use, enabling informed progression of their product development pipeline.