ARC Regulatory

ARC Regulatory

Biotechnology-Research

Belfast, Antrim
United Kingdom
Company Tagline

ARC is a specialist regulatory and clinical research company dedicated to the Precision Medicine, IVD and CDx industry.

Industry Category
Biotechnology-Research
Company Description

ARC Regulatory is a leading biotechnology research company committed to accelerating the development and accessibility of precision medicine. With a focus on regulatory compliance and clinical research, ARC Regulatory provides comprehensive support to pharmaceutical R&D companies worldwide. The company specializes in implementing unapproved diagnostics in clinical development programs, ensuring patient selection and stratification with unparalleled expertise.

Operating from its headquarters in Belfast, Antrim, ARC Regulatory serves as a strategic and integrated expert partner, offering full sponsor ownership of IVD studies conducted in parallel with clients' IND/IMP trials. ARC Regulatory's team of experts excels in IVD regulatory compliance, study design, approvals, and quality assurance, including vendor due diligence and management. The company's clinical research experts manage IVD studies, ensuring compliance with local and global GCP standards and the delivery of robust and reliable biomarker data.

To further enhance its services, ARC Regulatory has launched ARC360, a cutting-edge SaaS platform transforming how organizations access regulatory intelligence and tailor study-specific information for in vitro diagnostics. Located at Concourse Building 2, Catalyst Queen’s Road, Unit 1, Belfast, Antrim BT3 9DT, GB, ARC Regulatory continues to drive innovation and excellence in the precision medicine sector. We invite the management team to create a customized and exclusive company showcase and product listing on our platform, to further amplify their market presence.

ARC Regulatory est une société de recherche biotechnologique de premier plan engagée à accélérer le développement et l'accessibilité de la médecine de précision. Axée sur la conformité réglementaire et la recherche clinique, ARC Regulatory fournit un soutien complet aux sociétés pharmaceutiques de R&D du monde entier. L'entreprise est spécialisée dans la mise en œuvre de diagnostics non approuvés dans les programmes de développement clinique, garantissant la sélection et la stratification des patients avec une expertise inégalée.

Opérant depuis son siège social à Belfast, Antrim, ARC Regulatory agit en tant que partenaire expert stratégique et intégré, offrant une pleine propriété de commanditaire des études DIV réalisées en parallèle avec les essais IND/IMP des clients. L'équipe d'experts d'ARC Regulatory excelle dans la conformité réglementaire des DIV, la conception des études, les approbations et l'assurance qualité, y compris la diligence raisonnable et la gestion des fournisseurs. Les experts en recherche clinique de l'entreprise gèrent les études DIV, garantissant la conformité aux normes BPC locales et mondiales et la fourniture de données de biomarqueurs robustes et fiables.

Pour améliorer encore ses services, ARC Regulatory a lancé ARC360, une plateforme SaaS de pointe qui transforme la façon dont les organisations accèdent aux informations réglementaires et adaptent les informations spécifiques aux études pour les diagnostics in vitro. Située à Concourse Building 2, Catalyst Queen’s Road, Unit 1, Belfast, Antrim BT3 9DT, GB, ARC Regulatory continue de stimuler l'innovation et l'excellence dans le secteur de la médecine de précision. Nous invitons l'équipe de direction à créer une vitrine d'entreprise et une liste de produits personnalisées et exclusives sur notre plateforme, afin d'amplifier davantage leur présence sur le marché.

Key Personnel / Employees
Stephen McVittie Gary Mason David Lane Jeroen de Neijs

Compare Companies Side by Side

Compare ARC Regulatory with 3 companies in Biotechnology-Research

4 Companies
Comparison Field
ARC Regulatory
ARC Regulatory
Main Company
BlueBridge Technologies
BlueBridge Technolog...
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IRETI Life Sciences
IRETI Life Sciences
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Lucendra | MedTech Consulting
Lucendra | MedTech C...
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Founded Year
2006 2021
Company Size
11-50 2-10 2-10
City
Belfast, Antrim LA MONTAGNE, Pays de la Loire
Country
United Kingdom
Skills & Keywords Comparing with main company
27 Total Skills
Precision Medicine IVD Clinical Research Regulatory Compliance Biomarker Data Pharmaceutical R&D In Vitro Diagnostics 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
23 Total 1 Common 22 Unique
Match 4%
Common Skills:
Regulatory Compliance
Unique Skills:
21 CFR 820 AAMI TIR45 Connected Medical Devices Digital Diagnostics Digital health Digital Therapeutics +16
15 Total 15 Unique
Unique Skills:
agroécologie animation Audit interne Biodiversité développement durable DM +9
16 Total 16 Unique
Unique Skills:
21CFR4 21CFR812 21CFR820 & QMSR Cleaning (ASTM F3127 & ISO 19227) Ethylene Oxide (ISO 11135 & ISO 10993-7) GSPR 10 & 12 +10
4
Total Companies
2006
Oldest Founded
1
Countries
80
Unique Skills

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Alternative Company Names

This company is also known as

ARC Regulatory ARC监管 एआरसी नियामक ARC Regulatorio ARC التنظيمي এআরসি নিয়ন্ত্রক ARC Réglementaire ARC нормативный ARC Regulatório