EU GMP SERVICES
Simona Grahl Consulting is specialized in EU GMP matters from more than six years of hands-on advisory and laboratory experience for the production, writing, review, and update of the IMPD Dossiers for therapeutic dendritic cells for use in oncology trials (phases I and IIa/b), including all implied Chemistry, Manufacture and Control (CMC) tasks, Change Control review activities, Product Quality Review (PQR) activities for biopharmaceuticals and participation in preparation meetings for GMP inspections.
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