Key Knowledge Areas:
IND, NDA, MAA (MRP/DCP/CP/NP), IDE, PMA, DSUR, ACTD Dossiers
Global regions : America (North US, CA, Central, South), Europe, LATAM, Middle East, Asia, MENA, APAC
eCTD, NeeS, Paper and Electronic Paper Formats
10 year’s experience in Publishing software tools
Manage Quality Documentation supporting Document Compliance specification
8 year’s experience in Acrobat Pro and document compliance tools
BSc Degree “Chemistry and Quality” – Faculty Aix-Marseille – 1998
Diploma of Higher Education “Chemistry and Environment” – IUT Montpellier – 1997
Franck has extensive experience in Regulatory Registration Dossiers gained through a position in the Electronic Document Management Department (2000-2008). He has expertise in a wide range of Publishing types of dossiers and corresponding submission formats.
Prior to joining BlueReg, Franck was a Publishing and Document Compliance Expert (2000-2008) in the EDM Unit of Galderma R&D Company. In this role he was responsible for Publishing for Regulatory registration dossiers, externalisation of activities, and planning for Publishing activities and the Regulatory Document Compliance.
These experiences enabled him to extend and strengthen his skills in Submission dossiers (European CP, DCP, MRP and National Procedures, US NDA/IND/IDE/PMA, CA NDS, ACTD, etc…), in required (eCTD, NeeS, and Paper) Formats, in Publishing Project Management, and in Regulatory Document Compliance.
In May 2018, Franck moved to consultancy and joined BlueReg.