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Aubree K
@aubreekim
Estados Unidos
Inglés, Español, Francés
Sobre mí
I am an FDA regulatory specialist helping medical device and pharmaceutical companies achieve full compliance with U.S. FDA requirements. My expertise covers UDI compliance, eMDR filing, and IDE submissions for device trials, as well as IFU development to meet FDA standards. I also prepare NDA, ANDA, IND, and BLA submissions with precision, ensuring your applications are accurate, timely, and compliant. My goal is to simplify FDA processes so you can focus on innovation while I handle the regulations.
Habilidades
Aubree K
desconectado •
Revisa mis servicios
Reglamentos para dispositivos médicos
I will ensure fda udi compliance and prepare emdr filing for medical devices
Aprobación de la FDA y de la seguridad alimentaria
I will register your fda facility for food, drug, device, cosmetic and tobacco
