Socosur core historical business is Active Pharmaceutical Substances importation and distribution to the European Pharmaceutical manufacturing sites and Marketing Holders Solution provider of GMP API scale up for JEI French Biotechs, for human or veterinary drugs developments Toxicological Risk assessments for human and veterinary drugs: - HBELs : Permitted Daily Exposure (PDE) and Occupational Exposure Limits (OEL) / Occupational Exposure Bandings (OEB) - Material Safety Data Sheets (MSDS) - Toxicological characterization of impurities: organics (ICH Q3A, ICH Q3B, ICH M7), inorganics (ICH Q3D) and residual solvents (ICH Q3C) - Environmental Risk assessment (ERA) Cosmetics: - Product Information File (PIF according to EC No 1223/2009) - Audits of PIFs - Material Safety Data Sheets (MSDS) - Cross contamination Risk Analysis in the event of cosmetic product introduction in a multipurpose pharma drug product production line Medical Devices: - Biocompatibility report (ISO 10993) - Toxicological assessments of impurities according to ICH M7/ICH Q3B - Clinical evaluation report (MEDDEV 2.7.1 Rev4) - Audit of toxicological reports e-CTD drug product toxicological expertise: - 2.4/2.6 non clinical overview (ICH M4) - 2.5/2.7 clinical overview (ICH M4) Our clients are mainly based in Europe, but through our network of associates we have access to the world.