Your partner for Dx compliance in translational research

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Our Services

Solutions for the precision medicine and in vitro diagnostic (IVD) medical device industry
Engineers

Regulatory Consulting

Leading Regulatory Strategy Solutions for Diagnostics

  • Regulatory Strategy
  • Regulatory Submissions
  • Focused Medical Writing for IVD and CDx
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Clinical Expertise

Leading Clinical Expertise in IVD and CDx Development

  • Clinical Operations
  • Site Monitoring
  • Clinical Affairs
  • Biostatistics
Lab technician

Quality

QMS Auditing, Quality & Risk Management

  • QMS Auditing
  • Quality Management
  • Compliance
  • Risk Management

CRO

Managing your CRO clinical studies from start to end

  • Comprehensive Study Management
  • Site Selection, Contracting & Management
  • Compliance & Regulatory Support
Trainer

Training

Complementing your company's learning needs

  • Training modules delivered face-to-face
  • E-learning for beginners to advanced levels
  • Wide variety of topics

Join the pharmaceutical community that is already benefiting

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Customer Story

“At GenDx, we really appreciated the support and guidance provided by the ARC Regulatory team for our projects. Our overall experience has been very positive and the ARC team has shown to be very knowledgeable, responsive and collaborative. A great team to work with.”

Erica Kremer, Director Compliance at GenDx

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