eCTD v4.0 analysis based on first experiences in the US and Japan
RF QuarterlyEwa Dankowska, MSE, MS • Bernd Misselwitz, PhD • Ayako Okasasu, MS • Tim Powell, BSc (Hons) • Faizan Rahim, MSc • David Ross, MBA, MEM • Jason Ruby, BBA • Ankita Sunilkumar, MSRA, MPM
AsiaMedical DevicesPharmaceuticalsRegulatory harmonizationUnited States