Principal

Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. securedownload

Her expertise is in defining, implementing, and maintaining Quality Management Systems that are cohesive and properly interact with all areas of the organization. 

During these 20 years, Angela has actively participated in global regulatory inspections to include the US FDA in the capacity of  host, SME and scribe.  Through consulting with a variety of companies, Angela has worked with US FDA agents to ensure  compliance for her clients. 

The international experience obtained has assisted global organizations such as Johnson and Johnson, The Croda Corporation, Novartis, Hospira, Sanofi, and Quintiles to exceed regulatory expectations.

She has authored company best practices manuals and has trained on those procedures from the V-suite to the manufacturing floor. Angela works closely with the company’s staff to ensure a cohesive transition from non compliance to policy approval.