Your partner for Dx compliance in translational research

Lab technicians

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

  • Full Service CRO for Clinical Validation studies
  • Global Clinical Site Monitoring
  • Clinical Affairs
  • Biostatistics
  • Data Management
Lab technician

Quality

QMS Auditing, Quality & Risk Management

  • Vendor Due Diligence: Third-party QMS Auditing (Design Control, GCP, Software Lifecycle), periodic auditing
  • Quality Management System development (ISO 13485, ISO 20916, ISO 17025, ISO 15189 & ISO 14971)
  • Compliance, ownership of your Internal Audit Schedule
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CRO

Managing your CRO clinical studies from start to end

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

Sponsor Delegation

Acting as your trusted sponsor to seamlessly initiate and manage your FiH study

  • Diagnostic and Laboratory Vendor Identification
  • Regulatory Strategy Development
  • IVD Clinical Study Sponsor Oversight and Management
Trainer

Training

Complementing your company's learning needs

  • Training modules delivered via our LMS
  • E-learning for beginners to advanced levels for small teams or enterprise wide
  • Selected IVD topics, specific to the needs of the precision medicine sector

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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