a
aubreekim

Aubree K

@aubreekim
Vereinigte Staaten
Englisch, Spanisch, Französisch
Einige Informationen werden in englischer Sprache angezeigt.
Über mich
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.... Mehr lesen

Kompetenzen

a
aubreekim
Aubree K
offline • 

Meine Dienstleistungen

Regulierung für Medizinprodukte
I will ensure fda udi compliance and prepare emdr filing for medical devices
FDA-Zulassung und Lebensmittelsicherheit
I will register your fda facility for food, drug, device, cosmetic and tobacco