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CovarsaDx- Clinical Operations
- Medical Writing
- Regulatory Affairs
CovarsaDx provides full-service clinical research, regulatory consulting, and quality assurance for IVD and medical device trials, with expertise in FDA 510(k), De Novo, and PMA pathways.
Critical Path Institute- Clinical Operations
- Regulatory Affairs
- US FDA Regulatory Strategy
Critical Path Institute convenes pharmaceutical, government, patient, and academic organizations to optimize drug and medical product development through collaborative consortia, regulatory science initiatives, and clinical trial design optimization.