Elevation Strategic Development, LLC
Ashleigh Barkans currently serves as the VP of Clinical and Quality at Elevation Strategic Development, LLC, a position held since February 2022, and has also taken on roles as Director of Clinical & Quality Programs and Principal Consultant, Regulatory Compliance at the same company. Prior experience includes serving as Director of Quality and Regulatory at GID BIO, Inc. from January 2019 to February 2022, and a brief tenure in compliance and regulatory at Medtronic. Ashleigh held the position of Global Quality Manager at Terumo BCT from April 2017 to December 2018 and worked as an Investigator at the FDA from June 2010 to April 2017. Ashleigh holds a Master's degree in Education and Human Resources from Colorado State University and a Bachelor of Science in Biology and Chemistry from Metropolitan State University of Denver.
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Elevation Strategic Development, LLC
Elevation Strategic Development, LLC offers clinical and regulatory affairs consulting services for the diagnostic, medical device, and pharmaceutical industries. The company specializes in the design and implementation of regulatory and product development strategies for initial market entry, as well as global expansion. All services are fully tailored to each client’s needs, ranging from large perspective planning to detailed implementation, including regulatory strategy, product development plans, clinical study design, regulatory communication meetings, quality system design, clinical trial monitoring, and medical writing.