© 2017 by Maky Zanganeh & Associates

Christine Fazio has 29 years of industry experience with over 22 years in Regulatory in the pharmaceutical industry.  Chris has in-depth expertise in managing, preparing, and submitting NDAs in eCTD format, INDs for submission to CBER & CDER, pre-IND, pre-NDA, Pre sNDA, SPA, EOP2 (clinical, CMC) , clinical pharmacology, and CMC meeting requests/packages to the FDA, Breakthrough Therapy Requests, US IND/US Orphan Drug Annual Reports, US Orphan Drug requests, Fast Track requests, IND Safety Reports, Investigator’s Brochures and Protocol/Information Amendments to the FDA and international regulatory authorities, CTAs and CTNs, BLAs and in tracking /managing/submitting PMR/PMC and  Annual Reports for NDAs. Chris also has experience in QA compliance and QC.

 

Chris is currently an independent consultant.  Previously, she held senior executive and management positions of increasing responsibility within companies such as Pharmacyclics, Inc., Threshold Pharmaceuticals, Inc., Onyx Pharmaceuticals, Inc., Anesiva Inc., Intermune, Abgenix, Coulter Pharmaceutical, Inc., Athena Neurosciences, Inc.  She has also worked at Celtrix Pharmaceutical, Systemix, Inc., TAGO Immunologicals, Inc.   Chris earned her Bachelor of Science degree in Biology from San Francisco State University.