Cynthia L. Graves

Cynthia L. Graves, Ph.D., LLC is a specialized regulatory affairs consultancy providing strategic advisory services to the biotechnology and pharmaceutical industries. Founded and led by Dr. Cynthia Graves, a former Vice President of Global Regulatory Affairs at Amgen, the firm focuses on guiding companies through the complexities of global drug development and health authority interactions. The consultancy offers expertise in preparing regulatory submissions, including Investigational New Drug (IND) applications and Biologics License Applications (BLA), as well as providing representation during meetings with the FDA and other international regulatory bodies. Based in Thousand Oaks, California, the firm serves as a critical partner for emerging biotechs seeking to optimize their clinical and commercial regulatory pathways.