About Me

I am a 20+ years harmaceutical industry (13 years in SP500 companies). Extensive and skillful  in SAS programming and analytic for clinical Phase I-IV studies in varied therapeutically areas.

I did support IND, NDA, IDE, and/or IVD for 510(k) of class I, II, and PMA submissions of Class III in medical device.

I have proficiency in preparing FDA/EMA submission (focusing on ISE and ISE modules), with one Dermatology NDA approval at 2009.