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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.

Keywords

immunology, fda, laboratory developed tests, immunooncology, oncology, immunohistochemistry, digital pathology, biomarker development, rare diseases, pharmaceutical, companion diagnostics, clinical research, quality management systems, regulatory affairs, medical device, product development, clinical trials, assay validation, next generation sequencing, diagnostics, in vitro diagnostics, life sciences

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9
2019
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