CeDaFis Consulting

. Toxicologist (PhD, ERT), 30 years of experience in non-clinical /regulatory development (service provider and pharmaceutical companies) CeDaFis offers services in: - Project management and strategy/coordination in non-clinical development for biotechs, pharmaceutical companies and medical device manufacturers - Regulatory Affairs (CMC - Chemistry Manufacturing and Controls - and Non-Clinical): EU and US - Regulatory writing (Non-Clinical, CMC, IB) - Regulatory Support: "Gap analysis", due diligence and file audit (pharmacology, pharmacokinetics and toxicology) - Toxicological expertise: . Support for risk assessment . Determination of PDE (Permitted Daily Exposure) . Biological evaluation of medical devices (ISO 10993) . Writing "Position papers" (impurities, contaminants) . Toxicological evaluation of extractables and leachables (E&L) . Ad hoc consultation for support or recommendations - Technical expert for GLP audit/inspection Member of SFT (French Society of Toxicology) and SOFAQ (French Society of Quality Assurance) Cécile Fisch's activities are eligible to French Research Tax Credit (CIR) agreement E-mail: cecile.fisch@cedafis.com