Service providers

ARC Regulatory Ltd.

Solution provided
Technological/Validation solutions
Supplier indentity
General description
We are a niche provider of global regulatory and clinical research solutions to the precision medicine and in vitro diagnostic medical device industry. Our mission is to support companies, from the world’s top pharmaceutical and biotech leaders to medical start-ups, in their search to find kinder treatments and guide them through complex myriad regulatory and research requirements as they bring new medical discoveries to market.
Type of supplier
Clinical Trials Solutions Provider, Service Provider - CMO / CRO
Sector of activity:
Companion Diagnostics, Diagnostics / Devices and Services, Genomics, In vitro Diagnostics, Personalized Medicine
Activity description
Services provided
ARC regulatory is a Specialist CDx regulatory and clinical research organisation. Experts in CDx implementation in global clinical development progammes, US FDA IDE, EU IVDR and global CDx research compliance. Ethics submissions, clinical research laboratory site selection, vendor audits (QMS/GCP), central lab set up and study monitoring for CDx studies in global central laboratories. Regulatory strategy development, vendor due diligence (QMS/GCP), FDA BIMO inspection prep and global regulatory submissions for CDx device approvals.
Terms of availability for SMEs
None
Quality labels and accreditations
We work within a QMS compliant with ISO 13485
Contact information
Name
David Lane
Function
Global Alliance Manager
Phone number
0044 (0) 28 7963 9304
Address
Market Street 1 The Cornstore
Magherafelt
Ireland

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