VP Regulatory Affairs & Co-Founder Kristen K. Flaharty Pharm.D.

Dr. Flaharty has been involved in clinical research, teaching, and drug development for the past twelve years. She received her doctorate in pharmacology at the University of Michigan. A former employee of SmithKline Beecham, she has been a consultant to the pharmaceutical industry for the past seven years. This work has involved data analysis, clinical trial audits, scientific writing as well as assisting clients to develop regulatory and clinical strategies toward achieving FDA approval. A majority of work has revolved around assessing foreign-generated data for FDA acceptability, and subsequent design of appropriate development packages. Dr. Flaharty has presented clinical development plans and pre-registration packages at the Center for Drug Evaluation and Research on behalf of sponsors. She has also been integrally involved in preparing regulatory submissions including INDs, NDAs, clinical reports, study protocols, Pre-IND and Pre-NDA packages, and orphan drug applications. Most recently, she was a senior scientific/clinical force for a 900+ volume NDA filed in December 98, providing strategic and technical direction to medical writers and regulatory associates.

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