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Aubree K
@aubreekim
United States
English, Spanish, French
About me
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.
Skills
Aubree K
Offline •
See my services
Medical Device Regulatory
I will ensure fda udi compliance and prepare emdr filing for medical devices
FDA & Food Safety Clearance
I will register your fda facility for food, drug, device, cosmetic and tobacco
