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Sarah Marking, MS

Practice Lead, Quality Systems

Sarah leads regulatory submissions across various product categories. She combines her extensive industry experience, scientific expertise, and business acumen to provide practical solutions to regulatory challenges. Sarah supports regulatory strategy across all scientific areas including product design and development, manufacturing, and nonclinical and clinical study programs.

Prior to joining Venebio, Sarah served as an Associate Director of Quality Control at Meso Scale Diagnostics, a mid-sized assay development company.  In this role, she led the end-stage development of new products and managed the general quality functions of the business.  She placed a strong focus on continuous improvement, developing project proposals and leading large, interdisciplinary teams to solve complex operational problems.  She gained particular experience in the design and implementation of software solutions in production and testing processes, as well as the ongoing development of quality management systems.

Sarah works with clients to implement rigorous quality management systems and production processes to ensure effective manufacturing controls and facilitate continuous improvement. She specializes in helping clients create and navigate multi-product regulatory strategies and product line extensions. These strategies leverage existing scientific evidence through use of Supplemental PMTAs and/or TPMFs to minimize regulatory costs and timelines.

In addition to leading submissions to FDA’s CTP, Sarah works with clients to explore product submissions through both the NDA and ANDA pathways as the regulatory landscape continues to evolve.

Sara received her BA in Biology from Goucher College and her MS in Biology from the University of Maryland Baltimore County.