
Our Services
Solutions for the precision medicine and in vitro diagnostic (IVD) medical device industry
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Regulatory Strategy
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Regulatory Submissions
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Focused Medical Writing for IVD and CDx
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Full Service CRO for Clinical Validation studies
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Global Clinical Site Monitoring
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Clinical Affairs
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Biostatistics
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Data Management
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Vendor Due Diligence: Third-party QMS Auditing (Design Control, GCP, Software Lifecycle), periodic auditing
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Quality Management System development (ISO 13485, ISO 20916, ISO 17025, ISO 15189 & ISO 14971)
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Compliance, ownership of your Internal Audit Schedule
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Comprehensive Study Management
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Site Selection, Contracting & Management
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Compliance & Regulatory Support
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Diagnostic and Laboratory Vendor Identification
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Regulatory Strategy Development
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IVD Clinical Study Sponsor Oversight and Management
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Training modules delivered via our LMS
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E-learning for beginners to advanced levels for small teams or enterprise wide
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Selected IVD topics, specific to the needs of the precision medicine sector
Join the pharmaceutical community that is already benefiting

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