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Quality

Ensuring Compliance and Consistency at Every Stage

At Minaris Advanced Therapies, quality is a leadership priority and a core commitment to our partners, patients and ourselves. We apply a unified Pharmaceutical Quality System (PQS) based on ICH Q10 principles across all global sites, ensuring that every product is safe, effective and compliant throughout its lifecycle from development and technology transfer to commercial manufacturing and product discontinuation.

Our global quality framework integrates Quality by Design (QbD) principles, defining and monitoring the Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) as the foundation for process understanding, control strategies and lifecycle management. With a robust track record of successful regulatory inspections by the FDA, EMA, PMDA, MFDS, TGA and USDA, Minaris has demonstrated the systems, documentation and oversight necessary to ensure reliable outcomes for clients and patients worldwide.

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Proven
Global Compliance

Our global quality operations are aligned with international regulatory expectations and certified to the highest standards:

  • ISO/IEC 17025:2017 accreditation for select laboratory services
  • FDA drug establishment registration
  • EMA, PMDA, TGA and MFDS GMP compliance certificates
  • USDA registration for applicable products
  • More than 100 client and Qualified Person (QP) audits are hosted annually

Leadership and Governance

Digital-First Quality Systems

Quality Culture in Action

Global Quality Management System

A harmonized PQS aligns processes across all Minaris facilities, allowing for site-level flexibility. Core elements include product and process performance monitoring, CAPA, change management and management review, supported by knowledge management and quality risk management. These systems ensure consistent global quality while enabling seamless technology transfer and rapid decision-making.

Inspection and Regulatory Excellence

We maintain inspection readiness at all times, supported by a strong track record of successful inspections from the FDA, EMA, PMDA, MFDS, TGA and USDA. With structured readiness planning, mock inspections and CAPA oversight, our teams ensure smooth regulatory interactions and reliable audit outcomes.

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Change Management and Continuous Improvement

A structured change management system, supported by structured risk management, ensures compliant and timely implementation of changes. Continuous improvement is embedded through global and site quality plans, trending of deviations and complaints and lessons learned from inspections and audits. Quality awareness programs and staff recognition initiatives further strengthen our culture of accountability and continuous improvement.

Qualified Person (QP) Release

Our EU-based Qualified Persons provide compliant product release to European markets in line with EU GMP requirements, supported by global oversight and local expertise.

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Minaris Advanced Therapies maintains global quality systems for cell and gene therapies, including cGMP compliance, audit readiness, data-driven quality decisions, and continuous improvement from early phase to commercial supply.

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Minaris Advanced Therapies is dedicated to helping innovators in cell and gene therapy succeed. Whether you are in early-stage development or preparing for commercial launch, our end-to-end expertise, global reach and commitment to quality make us the ideal partner for cell and gene therapy manufacturing and GMP biosafety and analytical testing of all biologics.

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