Steven A. Kradjian, RAC

Mr. Kradjian had over 25 years of biopharmaceutical development experience from Vical lnc., Amgen Inc., American Medical Optics, and Alpha Therapeutic Corporation when he founded his Consultancy in 2004 and incorporated Conventus BioMedical Solutions in 2006. Mr. Kradjian earned an undergraduate degree in Chemistry from Occidental College in Los Angeles, and completed the Executive Development program for Senior Regulatory Affairs professionals at Kellogg Graduate School of Management at Northwestern University. He is certified by the Board of Regulatory Affairs Professionals Society and has served on various industry committees, product management committees, filed or supported numerous international clinical trial applications, and managed and participated in four product approvals. Since 1996 Mr. Kradjian has been an Instructor and curriculum advisor in Regulatory Affairs at UCSD Bioscience Extension and has given a number of invited lectures at industry conferences.

Roxanna Halich

Roxanna Halich, Regulatory Affairs Manager, has more than twelve years experience in the biotechnology industry. While at Conventus, she prepares or manages assorted regulatory submissions for the U.S. FDA Center for Biologics (CBER), Center for Drugs (CDER). She has prior experience preparing submissions for the FDA Center for Food Safety and Nutrition (CFSAN), the U.S. Environmental Protection Agency (EPA), and other regulatory agencies. Ms. Halich often operates as a primary point of contact with regulatory agency project managers on behalf of Conventus clients. She has earned her professional certificate in Regulatory Affairs for the Biomedical Industry. She is an expert in the Common Technical Document format of submissions, and is an expert in the use of Microsoft SharePoint® as an enterprise level document management tool. Her areas of expertise include regulatory submission strategy, submission planning and development, review and editing of technical and safety documents, maintenance of regulatory archives.

Cathy Bacquet, MS

Ms. Bacquet has over 12 years of regulatory affairs experience in biologics product development and has led project teams to finalize eight Investigational New Drug (IND) applications and seven Drug Master Files (DMF). She has also audited and established document tracking/control systems.