|
Ms. Chamblee is a regulatory affairs (RA) expert and inducted into the first class of RA Fellows.
She has over 20 years of experience developing, communicating, and implementing regulatory and compliance initiatives. Her
Agency experience includes working as an ombudsman and liaison for FDA. Her experience in regulatory affairs is in analyzing
and articulating strategies with manufacturers, as well as Agency experts and customers. She has extensive experience resolving
disputes with FDA. She is expert in drugs, devices, biologics, and combination products.
Ms. Chamblee provides a full range of domestic and international medical, regulatory and quality system services, e.g.,
regulatory strategic planning and implementation; preparation of FDA applications (IDEs, INDs,510(k), PMAs, PLA/ELA, and BLAs);
corrective action plans; client specific designs for on site employee regulatory and quality system training and development;
designated agent activities; FDA relationship guidance; and regulatory due diligence. Ms. Chamblee is Regulatory Affairs Certified
by RAPS and won a RAPS special recognition award in 2003 and 2006. She can be reached at achambleee@yahoo.com
|
