a
aubreekim

Aubree K

@aubreekim
Verenigde Staten
Engels, Spaans, Frans
Sommige informatie wordt in het Engels weergegeven.
Over mij
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.... Lees meer

Skills

a
aubreekim
Aubree K
offline • 

Bekijk mijn diensten

Regelgeving voor medische hulpmiddelen
I will ensure fda udi compliance and prepare emdr filing for medical devices
Goedkeuring FDA en voedselveiligheid
I will register your fda facility for food, drug, device, cosmetic and tobacco