ARC's purpose is to expedite access to precision medicine clinical trials for patients globally. We fulfil our purpose through our dedicated team of experts with unparalleled domain knowledge, and the important relationships we have developed with our global clients.
We are a Belfast-based Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector. We support many of the world's leading pharmaceutical R&D companies in implementing unapproved diagnostics in their clinical development programmes for patient selection or stratification, working as a strategic and integrated expert partner, taking full sponsor ownership of the IVD study being conducted in parallel with our clients' IND/IMP trial.
ARC's team of experts cover IVD regulatory compliance, study design and approvals, quality assurance including vendor due diligence and management along with a team of clinical research experts who manage the IVD study, ensuring it is conducted in compliance with local and global GCP, and that the biomarker data is robust and reliable.
To further support our growing client base and to expedite patient access to life-saving experimental medicines, ARC has developed and launched our SaaS platform, ARC360. ARC360 is transforming how organisations access regulatory intelligence and tailor study-specific information for using in vitro diagnostics to select and manage patients in IND trials. Powered by cutting-edge technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is designed to accelerate the initiation of complex clinical trials.
To find out more, visit www.arc-regulatory.com. Alternatively, call+44(0) 28 7963 9304 or email info@arc-regulatory.co.uk
Company Details
- Employees
- 40
- Founded
- -
- Address
- Concourse Building 2, Catalyst Queen’s Road, Unit 1,united Kingdom
- Phone
- +44(0)2879 639304
- se****@****y.co.uk
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Website
- arc-regulatory.co.uk
- Keywords
- EG, QSR, PMA, IDE, CE marking, ISO 13485, ISO 14971, Global Regulations, HEALTH CANADA LICENSE APPLICATIONS, IEC 62366, IEC 62304, Harmonised Standards, Regulatory Clinical Requirements, CDx, In vitro diagnostics, 28, 00, CDx Monitoring Services, GCP, Performance Evaluation.
- HQ
- Belfast, Antrim
Arc Regulatory Questions
Arc Regulatory's helpline number is +44(0)2879 639304
Arc Regulatory's website is arc-regulatory.co.uk
Arc Regulatory's LinkedIn profile is https://uk.linkedin.com/company/advance-regulatory-consulting-ltd-
Arc Regulatory has
40 employees.
View email and phone details for 40
employees at Arc Regulatory.
Arc Regulatory's industry is
Biotechnology Research
Arc Regulatory's top competitors are
Celerion,
Health Innovation Research Alliance Northern Ireland (Hirani),
Ailsebio,
Diaceutics Plc,
Sonrai,
Phion Therapeutics,
Fusion Antibodies,
Proaxsis,
Gran Lab Ltd.,
Cv6 Therapeutics, (Ni) Ltd..
Arc Regulatory's support email address is seamus@arc-regulatory.co.uk
Arc Regulatory's categories are Biotechnology Research
Arc Regulatory's founding year is 2009
