. 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
Company Details
- Employees
- 1
- Founded
- -
- Address
- 42, Cours Pierre Vasseur, Palaiseau,île-De-France 91120,france
- Industry
- Research Services
- NAICS
-
Scientific Research and Development ServicesResearch and Development in the Physical, Engineering, and Life SciencesResearch and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Keywords
- Regulatory Affairs, Medical Device, Non-clinical Development, GLP, Project Management, Risk assessment, Regulatory writing, Non-clinical Strategy, FDA, EMA, Non-clinical studies, Regulatory studies, E&L, Toxicology expertise, CMC, Gap analysis, Combination product, Medicinal product, Quality, CROs, Due Diligence.
- HQ
- Palaiseau, Île-de-France
- Competitors
- MAAsiRNA, Pathology Experts GmbH.
Cedafis Consulting Questions
Cedafis Consulting's LinkedIn profile is https://fr.linkedin.com/company/cedafis-consulting
Cedafis Consulting has
1 employees.
View email and phone details for 1
employees at Cedafis Consulting.
Cedafis Consulting's industry is
Research Services
Cedafis Consulting's top competitors are
Maasirna,
Pathology Experts Gmbh.
Cedafis Consulting's categories are Research Services
Cedafis Consulting's founding year is 2021
