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ARC Regulatory Ltd.
ARC Regulatory Ltd.
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Projects
Clinical Research *
Clinical Reporting
Product Development
Real World Data Research
Study Operations & Management
Trial Design & Planning
Commercialization *
Brand Planning & Activation
Customer Engagement
Finance & Investment *
Financial Services
Investment Banking
Market Access & Policy *
Global Market Access
Government Policy
Medical Affairs *
Defining the Value of Medical Affairs
Evidence Generation
Scientific Communications Development
Strategic Communications Planning
Strategic Stakeholder Engagement
Pharmacovigilance *
Risk Management
Safety Systems
Quality & Mfg *
Facilities & Equipment
Production & Supply Chain
Quality Management
Testing & Release
Regulatory *
Compliance
Labeling & Promotions
Maintenance & Renewals
Transparency & Disclosure
Technology & Operations *
Automation & Efficiency
Data & Analytics
Digital Health Solutions
Early Development
Informatics Infrastructure
Operations
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ARC Regulatory Ltd.
Unmatched Expertise in Translational Biomarkers and Regulatory Compliance
Specializing in drug information, this company offers unparalleled expertise in supporting translational biomarkers in early clinical development. By leveraging their proprietary systems and risk-based monitoring of central testing laboratories, they ensure seamless fulfillment of sponsor obligations throughout the clinical development life-cycle. Their comprehensive suite of services includes analytical testing capabilities, R&D compliance support, and on-demand training across GCP, IVDR, and other regulatory requirements. Their mission is to support pharmaceutical and biotech R&D companies in expediting high-quality clinical research, ultimately aiming for kinder and more effective patient treatments.
Focused on providing expert guidance to diagnostic companies, this firm assists in meeting manufacturer and sponsor expectations through tailored regulatory strategies and full CRO support for clinical performance studies. They offer a range of SaaS digital products like the regulatory navigator and laboratory toolkit, designed to streamline compliance for precision medicine clinical trials. Their commitment to face-to-face interaction and strategic client engagement underscores their goal of promoting platinum standard in vitro and companion diagnostic clinical research, ensuring robust clinical data and sound decision-making for the next phase of clinical development.
Unmatched Expertise in Translational Biomarkers and Regulatory Compliance
Specializing in drug information, this company offers unparalleled expertise in supporting translational biomarkers in early clinical development. By leveraging their proprietary systems and risk-based monitoring of central testing laboratories, they ensure seamless fulfillment of sponsor obligations throughout the clinical development life-cycle. Their comprehensive suite of services includes analytical testing capabilities, R&D compliance support, and on-demand training across GCP, IVDR, and other regulatory requirements. Their mission is to support pharmaceutical and biotech R&D companies in expediting high-quality clinical research, ultimately aiming for kinder and more effective patient treatments.
Focused on providing expert guidance to diagnostic companies, this firm assists in meeting manufacturer and sponsor expectations through tailored regulatory strategies and full CRO support for clinical performance studies. They offer a range of SaaS digital products like the regulatory navigator and laboratory toolkit, designed to streamline compliance for precision medicine clinical trials. Their commitment to face-to-face interaction and strategic client engagement underscores their goal of promoting platinum standard in vitro and companion diagnostic clinical research, ensuring robust clinical data and sound decision-making for the next phase of clinical development.
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Heather Taylor
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