Melanie Bell, MS, RAC-Drugs

Melanie specializes in global clinical trials supply chain management and in developing strategic supply forecasts and supply plans.  She is experienced in the preparation, tracking, and submission of U.S., European, and Canadian regulatory documents and in the lifecycle management of IND and NDA programs.  Melanie provides CMC and cGMP compliance support, as well as project management assistance for integrated product development projects.  She also provides support in reviewing and developing quality systems and performing quality assurance functions such as lot release, coordinating and performing quality investigations, and manufacturing change control management.  Melanie has an M.S. in Bioscience with an emphasis in regulatory affairs from the Keck Graduate Institute of Applied Life Sciences and a B.S. in Genetics from the University of Georgia.  She maintains Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS).