STEVEN A. KRADJIAN, RAC
Founder and Owner
Mr. Steven Kradjian is a veteran regulatory leader, drawing from his more than 25 years of experience in biopharmaceutical regulatory affairs and development, ranging from product candidate selection through late stage clinical development with cellular and gene therapies products, small molecules, recombinant proteins, monoclonal antibodies and combination products in a wide range of therapeutic areas, and investigational vaccines in populations at risk for infectious disease vaccines. READ MORE.
CHRISTINE M. WOODS, MA
Vice President, Regulatory Affairs
Christine M. Woods is an agile Vice President of Regulatory Affairs at Conventus Biomedical Solutions. She has held several positions in Regulatory Affairs at various pharmaceutical companies. She has over 30+ years’ experience in progressive professional experience in the pharmaceutical, biologic & device industries in RA, quality and R&D positions. Thirty years of regulatory experience with a broad understanding of product development. Over 30 years of experience hiring, supervising, developing & READ MORE.
Regulatory Operations Manager
Thiru Vodnala is a Regulatory Operations Manager at Conventus Biomedical Solutions. He has held several positions in Regulatory Operations at various multi-national pharmaceutical companies focused on eCTD and Advertising and Promotional Material submissions. He has over 4 years’ experience in preparing and submitting eCTD submissions for applications such as INDs, NDAs, BLAs, ANDAs and DMFs using various publishing tools as per USFDA guidelines. He has extensive experience and knowledge READ MORE.
KURT NORTON, MS
Regulatory Affairs Senior Associate
Kurt Norton is a Regulatory Affairs Senior Associate at Conventus Biomedical Solutions. He is an accomplished Scientist and Regulatory Affairs Professional. Kurt has held multiple Scientist positions in biotechnological companies developing and manufacturing in vitro diagnostic assays, medical devices and biologics. Kurt has regulatory affairs experience with product candidates in development and READ MORE.
Lisa is a professional writer and editor with credits in multiple local and national publications including the Los Angeles Times and the San Diego Union Tribune and NPR/KPBS Public Radio. Her work includes writing and editing annual reports, grant proposals, speeches, company newsletters, direct mail campaigns, articles, and web and social media content, for both corporations and nonprofit organizations ).
CONVENTUS BIOMEDICAL SOLUTIONS, INC.
is a privately-held consulting firm specializing in development solutions and global regulatory strategies and submissions for investigational medicinal products in early development stages through Phase 3. The Conventus team includes full-time expert personnel, and expert affiliates with deep expertise in multiple technical disciplines, who together comprise an integrated team with successful experience in a broad range of therapeutic areas and vaccine indications.