Robert Timko
Dr. Robert J. Timko is a Consultant/Subject Matter Expert (SME) at Shabas Solutions LLC with over 50 years of experience working in the pharmaceutical industry in various technical and managerial positions at Johnson & Johnson and AstraZeneca Pharmaceuticals. He currently supports NIH National Institute of Neurological Disorders and Stroke (NINDS) and Helping End Addiction Longterm (HEAL) Blueprint Therapeutic Network (BPN) programs.
Dr. Timko has worked with a variety of traditional and novel dosage forms across multiple therapeutic areas and interacted with global Health Authorities on a diverse range of CMC topics. He is well versed in the technical and regulatory documentation requirements for INDs/IMPDs, NDAs/MAAs, and sNDAs/Variations. Dr. Timko is considered a SME with in-depth knowledge of Quality-by-Design, Process Analytical Technology, Real Time Release, and Continuous Manufacturing Processes in the current regulatory environment.
Over the years, Dr. Timko has been involved in preparing and/or reviewing more than 40 marketing applications either in a pharmaceutical development or regulatory capacity for innovator and generic compounds for a variety of small and large molecule dosage forms, including but not limited to, immediate and extended release dosage forms, injectables, topicals and liquids.
