Toxicon Srl

OVERVIEW Toxicon provides a wide range of expert advice services in regulatory fields and in the areas of toxicology, pharmacology and occupational medicine for companies and institutions. Toxicon assists large companies and SMEs for a complete regulatory compliance. Moreover, Toxicon works in partnership with institutions, industries and associations for R&D and compliance projects. Our know-how is based on a solid academic background in risk assessment. Our team consists of specialists in different areas: physicians, pharmacologists, biologists, chemists, economists and lawyers. We believe that complex problems can be solved with success and quality only through teamwork. SERVICES PROVIDED Overall services: Guidance on regulatory interpretation, regulatory compliance support, auditing. REACH: Data sharing, Sief and consortium management. Data gap analysis and testing strategy development, including the use of QSAR models. Dossier preparation (Inquiry, Lead and Member Registrants) including CSA/CSR. PPORD notification. SDS and e-SDS. Compliance check with exposure scenario (ES), scaling, CSR-DU development. ES development for mixtures. Applications for authorisation including SEA. CLP/GHS: Hazard assessment, classification, labelling and notification in compliance with EU and US GHS. BPR Regulation: Data sharing agreements, dossier development for active substances approval and biocidal products authorisation. Cosmetic products: Safety assessment, product information file, notification. Medicines: Common Technical Document, genotoxic impurities assessment, environmental risk assessment. Occupational medicine: Risk assessment and management according to Directive 98/24/EC and national law (D.Lgs. Other: Training courses, webinars and bespoke/inhouse training for companies, universities and institutions.