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IVD & Companion Diagnostics EXPERTISE


IVD Trial Sites Managed


IVD Clinical Trials


IVD Regulatory Submissions


Monthly IVDR Tech File & Gap Assessments

NAMSA’s stand-alone IVD business unit, the only within the Contract Research Organization (CRO) industry, is focused on meeting the unique product development needs of IVD manufacturers. We help clients fast-track the commercialization of life-changing IVD products through our proactive approach and in-depth knowledge of IVD requirements.

Our IVD experts partner with your team on a global scale and in a variety of capacities. Some clients choose to outsource all regulatory, quality, reimbursement and clinical research initiatives, while others collaborate with us on portions of their IVD regulatory or clinical study processes. No matter your needs, NAMSA is the most flexible IVD CRO in the industry and we pride ourselves on delivering high-quality results by leveraging our collective global expertise. We partner with you every step of the way to ensure your success.

Some of our most frequently requested IVD therapeutic areas include:

  • Clinical Chemistry
  • Companion Diagnostics
  • Direct to Consumer Testing (DTC)
  • Drugs of Abuse Testing
  • Hematology
  • Hemostasis/Coagulation
  • Histology and Cytology
  • Immunochemistry
  • Microbiology Culture
  • Molecular Diagnostics
  • Point of Care Testing

NAMSA invites you to learn more about our IVD business unit and services by clicking here.

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NAMSA Start-Up 360: Accelerating IVD Product Development
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NAMSA Guide: In Vitro Diagnostic (IVDR) Readiness Guide
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Do’s & Don’ts for Early-Stage IVD Product Development & Risk Mitigation
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