About Globiox
Globiox, Inc. is a quality and regulatory compliance consultancy based in Austin, Texas, United States. Founded in 2010, the company supports pharmaceutical, medical device, biotechnology, biologics, cell and gene therapy and cannabis organizations, together with contract research organizations and clinical laboratories. Its technology practice covers electronic quality management system implementation, configuration, data migration, system administration and post-go-live optimization. Alongside this, Globiox provides GxP auditing and consulting across manufacturing, clinical, laboratory and distribution practices, including internal and supplier audits, REMS audits, CAP/CLIA laboratory audits and mock FDA inspection readiness assessments. The company is also an official reseller of accredited training and certification courses from PECB, a certification body operating under ISO/IEC 17024. Globiox provides remote and on-site services to clients across the United States, Canada, the European Union and the United Kingdom.
Services
Globiox provides the services listed below.
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Quality Management System Consulting
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Regulatory Affairs Consulting
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eQMS Implementation Support
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eQMS System Administration
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Computerized System Validation Consulting
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GxP Compliance Auditing
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Internal Auditing
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Supplier Auditing
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Audit Readiness
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Quality and Regulatory Training
Life Science Expertise
Industries Supported
Globiox supports the life science industries listed below.
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Pharmaceuticals
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Medical Devices and MedTech
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Biotechnology
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Contract Research Organizations (CROs)
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Biologics
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Cell and Gene Therapy
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Cannabis
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Clinical Laboratories
Regulatory, Quality, and Compliance Expertise
Globiox has relevant expertise in the areas outlined below.
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GxP
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ISO 13485
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21 CFR Part 11
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EU GMP Annex 11
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GAMP 5
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Good Manufacturing Practice (GMP)
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Good Clinical Practice (GCP)
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Good Laboratory Practice (GLP)
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Good Distribution Practice (GDP)
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Good Clinical Laboratory Practice (GCLP)
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Good Pharmacovigilance Practice (GVP)
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ICH E6 (GCP)
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21 CFR Part 58
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OECD GLP
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CLIA
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CAP Accreditation Standards
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FDA REMS
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ISO 9001
Countries and Markets Served
Globiox serves clients in the countries and markets listed below.
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United States
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Canada
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European Union
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United Kingdom
How Globiox Works with SimplerQMS
Globiox supports life science organizations evaluating or adopting SimplerQMS, drawing on more than a decade of experience configuring, validating and migrating data into electronic quality management systems. Areas of collaboration include implementation planning, process creation and improvement, document migration preparation, and post-go-live system administration. Its GxP auditing practice also helps clients define and test quality processes before and after configuration.
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