Quality Services Overview

Dedicated to CGMP Compliance and Quality Excellence

Samsung Biologics is driven to deliver world-class biologics CDMO services by upholding stringent cGMP compliance and regulatory standards. All CGxP operations align with global health authority requirements to ensure the safety, quality, and efficacy of biopharmaceutical products across our facilities.

Integrated GMP Quality Systems and Digital Infrastructure

Our unified Quality team manages quality assurance and quality control across all sites, providing a centralized approach to biologics CDMO operations. Samsung Biologics integrates digital platforms to ensure proactive quality management. A structured GMP training program certifies all personnel involved in cGMP operations, maintaining global compliance. Explore more about our Biopharma Manufacturing solutions.

  • EQUIS

    : Enterprise Quality Unified
    Information System

    Our Electronic Quality Management System (eQMS) supports change control, documentation management, and event tracking across all CDMO services. This infrastructure enhances compliance, efficiency, and transparency throughout the quality lifecycle.
  • LMS

    : Learning
    Management System

    The LMS platform ensures consistent GMP training, qualification tracking, and certification for all personnel. This system supports our commitment to quality assurance services by keeping our workforce aligned with regulatory standards.
  • LIMS

    : Laboratory Information
    Management System

    LIMS supports round-the-clock data integrity and testing workflows in quality control testing. It provides centralized access to lab data, enabling better decision-making in Analytical Development and regulatory filings.
Samsung Biologics leverages AI-driven platforms to better adapt to the changing regulatory landscape, streamline quality assurance, and improve manufacturing processes.

Quality Culture and Regulatory Excellence

The independent Quality Unit ensures all cGMP operations align with global regulatory guidelines. Our Quality Control (QC) and Quality Assurance (QA) teams rigorously maintain compliance across product lifecycles. With robust regulatory affairs support, we guide clients from clinical development through IND/IMPDs and BLA/MAAs. Learn more about our Biopharma Development and Late Discovery support.

  • Quality Control Services

    Our QC services include analytical testing operations, method transfer and optimization, facility monitoring, sample management, and long-term stability testing programs. These support robust data packages for regulatory subamissions and commercial release.

  • Quality Assurance Oversight

    Samsung Biologics' QA team oversees GMP facility operations, quality systems, analytical development, audit readiness, and data governance. This ensures end-to-end compliance across all biologics CDMO activities. Read more about our Analytical Testing capabilities.

  • Regulatory Affairs Support

    Our Regulatory Affairs experts provide strategic consulting, intelligence monitoring, and document preparation, including CTD modules and response management. We support clients through every stage of regulatory interaction, from IND submission to market authorization applications. Visit our Resources to explore submission readiness tools.

  • 0
    Regulatory approvals
    (FDA, EMA, PMDA, etc.)
  • 99%
    Batch Success Rate

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