a
aubreekim

Aubree K

@aubreekim
Stati Uniti
Inglese, Spagnolo, Francese
Alcune informazioni sono riportate in lingua inglese.
Chi sono
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.... Continua a leggere

Competenze

a
aubreekim
Aubree K
offline • 

Consulta i miei servizi

Regolamentazione per dispositivi medici
I will ensure fda udi compliance and prepare emdr filing for medical devices
FDA e autorizzazione alla sicurezza alimentare
I will register your fda facility for food, drug, device, cosmetic and tobacco