Brian Cudney, MBA, CSSBB

Director, Chemistry, Manufacturing and Controls

Brian Cudney, MBA, CSSBB, is Director, Chemistry, Manufacturing and Controls (CMC) for Cardinal Health Regulatory Sciences.

Role responsibilities

Cudney is responsible for scientific and regulatory consulting activities associated with pharmaceutical product development and global regulatory affairs, including the preparation of investigational and marketing applications, the preparation of post-approval regulatory submissions and providing and executing strategies for global registrations.

Professional experience

Cudney has more than 20 years of experience in the pharmaceutical industry, focusing in research and development (R&D), analytical development, technical transfer and scale-up of pharmaceutical products in a variety of dosage forms. Cudney also has extensive experience with regulatory strategies (US and ex-US), maintaining regulatory compliance, intellectual property protection, technical writing, contract manufacturing and formulation development for a variety of different dosage forms and drug substances.
Prior to joining Cardinal Health in 2012, Cudney worked at Nesher Pharmaceuticals, where he held positions in R&D and quality assurance validations. Other previous roles included serving as a biopharmaceutical researcher at KV Pharmaceuticals, regulatory CMC at Achillion Pharmaceuticals and a formulation scientist at Bayer.

Education

Cudney received a master’s degree in business administration from the University of Connecticut and a bachelor’s degree in chemistry from Ball State University.

Areas of Expertise


Quality-by-design (QbD) strategies

Preparation of regulatory applilcations

Analytical development

Formulation development

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