Gerald De Fontenay Email & Phone Number

Pau Area, France

Cebiphar is one of the most reliable service provider for the Pharmaceutical Industry (Human and Veterinary). As a part of Teranga Groupe (with ACM Pharma for microbiological analyses and UPS Consultants for training and consulting activities), Cebiphar completes a broad panel of services to support Drug development..As an expert in analytical sciences:, I support an upgrade of the services in order to be ready for ICHQ14 and ICH Q2(R2), USP <1210> and <1220> and any other evolution of the regulation, both at the headquarters (located near Tours - Fondettes- in the Loire Valley) and at the new analytical laboratory in Toulouse. After successful inspections from French authorities and from FDA in 2017, the cGMP Quality System from Fondettes is now fully implemented in the Toulouse laboratory, which has also been inspected by French authorities.

Pau Area, France

You generate thousands of analytical results. But are they reliable enough? Even with validated methods, you may generate false positive OOS results, and you spend a lot of time to justify these results. Take out a complete overview of your methods from your development and validation results. Review historical data for troubleshootingData review, Validation and transfer protocol design, report writing, transfer coordination are items for which I will become soon available through training or consultancy.This activity is implemented through the company Cebiphar.

Pau, Toulouse, Montpellier,Tulle, Bordeaux, Marseille

Integration of our Pharmaceutical Analysis Solutions within Eurofins network of companies/laboratories. Change management. Networking within European laboratories.

France

Harmonization and coordination of the "Pharmaceutical Analysis Solutions" Business Unit across the group.Amatsigroup is a CDMO offering to its customers (from biotechs to global human and veterinary pharmaceutical players), comprehensive services throughout the value chain of drug development. Its Regulatory Team enhances the Development process to meet all regulatory requirements at each drug development stepAmatsigroup, with state-of-the-art facilities, has developed know-how and experience, in different strategic activities: 1) Bioservices, 2) Pharmaceutical Analysis Solutions, analytical testing for chemicals and biologics 3) Formulation Development and Manufacturing, for chemicals and biologics 4) Clinical Trial Material Logistics.Amatsigroup results from the combination of several complementary specialized companies:- CRID Pharma (renamed Amatsi), for Formulation development, Non Sterile Manufacturing and Clinical Trial Supply- Avogadro, for Bioanalysis and Pharmaceutical Analysis and testing- Avepharm for Microbiological testing - DBI for Sterile Manufacturing- SEPS for formulation development, bioavailability enhancement and non sterial manufacturing- Saint-Augustin (former Pierre Fabre site) for Pharmaceutical Analysis- QBiologicals for Biomanufacturing- Disposable Lab for Sterile Manufacturing Amatsigroup (CDMO) operates from facilities based in France, Belgium and a US commercial office.

Geneva Area, Switzerland

Management of multi-site projects within the network of 19 SGS LSS laboratories and the different Centers of Excellence (Biocharacterization, Biosafety, Extractable and Leachable E&L, Stability studies, QC release, Utilities testing - Water & gases analyses, cleaning validation -, process validation, etc.Training sessions for QA and Operations (North America, Europe and Asia) regarding method development, verification, validation and transfer (>250 people, >15 sessions), in order to improve knowledge of method performances and importance of method verification ("When you need to be sure").Technical and regulatory support to operations worldwideup to September 2012 = EU Strategic Business Manager: At the Regional scale, overview of Regulatory changes and review of customers needs, networking, leverage of local synergies between the 9 EU laboratories for multisite projects

Scientific organization of 2012 International Congress of SFSTP "Product understanding for a better product Quality" - Pharmaceutical development, - industrialization, - regulatory expectations from ANSM, EMA, FDA, - PQR,- Knowledge Management, - QbD, - ICH Q8-Q9-Q10, - etc...Montpellier, 6-7 June 2012

Toulouse Area, France

Management of a 30-people team of analysts Expertise on method validation, including robustness studies, and analytical method transfer focusing on data reliability (with statistical interpretation)Stability studies managementConsulting for Pharmaceutical IndustryTraining skills

Pharmacokinetics, Drug metabolism, Residue studiesVeterinary products

Training period in Sevilla, Spain.R&D farm for pesticide trials on cotton and citrus trees

Phd, Chemistry

Activities and Societies: Organic and analytical chemistry, Biochemistry, statistics

Engineer, Agrochemistry

Activities and Societies: BDE