CLIENT SIZE GEOGRAPHY TIME LINE CASE STUDY: THERAPEUTIC AREA DISCOVERY / NON-CLINICAL CLINICAL DEVELOPMENT MARKETING AUTHORIZATION / APPROVAL PRODUCT MAINTENANCE EU Over 10 years Small Biotech Autologous cell product (cartilage defect) Cartilage defect CLIENT NEED OUR SOLUTION PHARMALEX VALUE TO CLIENT Client was a small biotech company developing an autologous cell product for cartilage defects Development and regulatory support over 10 years needed for: Regulatory strategy CMC writing Nonclinical writing Clinical writing eCTD preparation, submission Management of EU Centralized Procedure Preparations and conduct of Scientific Advices and Oral explanation Experts available with ATMP experience in regulatory, quality, nonclinical and clinical Access to know-how from many EMA submissio

Join for free to read