CMC & Quality
Valerie Anaudinaud-Lignier is responsible for the management of projects involving the development of Chemistry Manufacturing and Controls (CMC). She provides scientific, technical and regulatory expertise and is involved in reviewing and preparing regulatory pharmaceutical documents: CMC sections of IMPD/IND, Briefing Packages for Scientific Advice, Variations, CTD module 3, and Quality Overall Summary of MAA.
With a strong industrial experience in Quality Control, Analytical Development and Quality Assurance (GMP), Valérie contributes actively in the elaboration of product development plans and participates in the preparation of supportive documents such as stability and method validation reports, process optimisation/development reports. In addition, Valérie provides support to management of subcontracting activities to CROs/CMOs and technology transfer.
Valerie brings 12 years of experience in the Pharmaceutical Industry including 8 years at Théramex (subsidiary of TEVA group), Monaco, and 4 years at Grimberg, a global French-based Company. She was in charge of the Quality Control (IMPs and marketed products) and Analytical Development of products in therapeutic areas such as gynecology, gastroenterology, otorhinolaryngology and supplementation in mineral and vitamins. In this role Valérie gained experience in chemistry of small molecules, analytical method development and validation, specification set-up as well as stability testing. She was involved in the pharmaceutical development, life-cycle management and dossier authoring of many dosage forms such as solid (tablet, capsule), semi-solid (cream, gel), liquid (suspension, solution) and flexible (transdermal patch) forms.
Valerie obtained a MSc in Physics and Chemistry and a Ph.D. of Pharmaceutical Sciences from the University of Bordeaux (France) in the field of polyphenol chemistry. She is based in our Lausanne office.