Aubree K

@aubreekim

États-Unis

Anglais, Espagnol, Français

Certaines informations sont présentées en anglais.

À propos de moi

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.... Plus d’infos

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