Elevation Strategic Development, LLC
Staci J Kearney, PhD, RAC, is a highly experienced professional in clinical, regulatory, and scientific consulting across the diagnostics, medical device, and pharmaceutical industries. As the Founder and Chief Executive Officer of Elevation Strategic Development, LLC since January 2019, Staci provides strategic guidance in regulatory and product development. Prior to this role, Staci served as Vice President of Clinical & Regulatory Affairs at Flagship Biosciences, Inc., leading IVD development strategies and regulatory agency interactions. Staci's background includes various positions that encompass clinical operations, regulatory intelligence, and scientific research, with a doctorate in Immunology and a BS in Microbiology and Bacteriology. With extensive expertise in navigating complex regulatory landscapes and fostering strategic partnerships, Staci is well-regarded in the healthcare sector for driving innovation and compliance in diagnostic applications.
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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.