EDOUARD GUILLABERT
MSc | MTOPRA
Founder, Director & CMC Consultant
Edouard is an independent Pharmaceutical Consultant in the CMC field (including Pre-formulation, Formulation, Clinical Drug Product Manufacture, analysis & Characterisation) with over 20 years of experience in the pharmaceutical industry (R&D), Contract Development Manufacturing Organisation (CDMO) and Start up.
After studying chemistry, physico-chemical analysis and quality at the Université Claude Bernard de Lyon (France) Edouard joined Pfizer R&D site (Sandwich, UK) in 2003 where he gained a broad expertise in the pharmaceutical field from early stage discovery support to late phase development and technical transfer for oral, parenteral and inhalation dosage form products.
Late 2011 Edouard then worked for a CMC consultant on an ad-hoc basis to enhance his knowledge and understanding of the regulatory requirements before he returned to Pfizer R&D in 2012 to work in the Material Sciences group.
Edouard then joined a Contract Development Manufacturing Organisation (CDMO) based in Reading (UK) in 2014 where he worked for 2 years and where he mainly focussed on oral delivery successfully leading, supporting and delivering small preclinical formulation studies as well as multiple large clinical phase formulation/manufacture projects for international clients.
Edouard holds a Prince2® Practitioner certification in project management and is Bilingual French/English.
Early 2016 Edouard founded GalenAuxi Ltd to support companies in his fields of expertise which range from materials sciences to drug product development and Clinical Trial Manufacturing (CTM) including associated documentation and project management.
Key Specialities: formulation (inhalation, Oral, Parenteral), pre-formulation, pharmaceutical, R&D, CMC, CTD, IMPD, BMR, Prince2, project management, physico-chemical properties, solubility, stability, compatibility, material sciences, dry powder, Spray Dried Dispersion (SDD), liquid, solution, suspension, technical transfer, analysis (including HPLC, UV, LC-MS, PXRD, DSC, TGA, DVS, FTIR, FT-Raman, Optical microscopy, Particle Sizing).