Melanie S. Bell, MS, RAC

Areas of Expertise:

Melanie Bell, MS, RAC-Drugs

Associate Principal Consultant

Melanie provides support in reviewing and developing quality systems and performing quality assurance functions such as coordinating and performing quality and complaint investigations, manufacturing change control management, and lot release. She provides CMC and cGMP compliance support, as well as project management assistance for integrated product development projects. Melanie 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. She also is a clinical research specialist with experience in clinical trials material management, the design of clinical protocols, and in the management and oversight of clinical programs. 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).