Andrea Chamblee Email & Phone Number

I have over 35 years experience as a Food and Drug Attorney, I am a trained FDA investigator. I am a regulations and compliance expert, and agency liaison. I am an award-winning editor and writer. Admitted: MD Bar (1986), DC (1989).Distinguished Service and Leadership Awards (FDLI 2022). RAPS Fellow 2008. Everytown Fellow (2020).RAC certified (RAPS 1993). Effective Communication certified (RAPS 2021). Executive Development Program Graduate 2008, Kellogg School, Northwestern University, 2008.I prepare for, manage, and respond to FDA inspections and regulatory actions. I successfully propel products and solutions for all regulated products: assess, identify, collaborate, implement compliant solutions in resource-limited environments to secure and expand approvals while improving productivity. I identify and deliver solutions on quality, compliance and enforcement. I am experienced with all commodities and issues from concept to commercialization, reimbursement, inspections, and compliance. I am an experienced team leader and motivator, a coach, and mentor.

Listed skills include Regulatory Affairs, Fda, Biotechnology, Clinical Trials, and 43 others.