Quality Assurance & Control
At Medilux Laboratories, Quality is the cornerstone of our operations. Guided by Quality by Design (QbD), we integrate quality principles across all tasks—from training to customer service—ensuring continuous improvement, higher productivity, and compliance.
Quality Management System (QMS)
Our QMS is designed to ensure consistent quality and timely delivery. We have a robust Quality Management System that integrates GXPs (cGMP, GLP, GDP, GSP, GEP) and ISO standards.
Key components of our QMS include:
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Process Management & Control Systems
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Quality Assurance
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Technology & Infrastructure Management
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Risk Assessment & Management
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Compliance & Training
We operate in a comprehensive structure that incorporates standards from USFDA, EU-GMP, PMDA, WHO-GMP and ISO. This ensures we stay ahead in delivering top-tier quality on a global scale.
Compliance: A Way of Life
Compliance is fundamental to how we operate at Medilux. It's not just a matter of passing audits—it’s about doing things the right way. Medilux undergoes over 100 audits annually from customers, sponsors, and regulatory bodies, further validating our commitment to quality and best practices.
OUR OTHER CAPABILITIES
From molecule to market, our Centre of Excellence links discovery with scalable production.
Research & Development
A robust, integrated approach keeps your supply secure and efficient.
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Supply Chain Management
Seamlessly aligning drug development with global regulatory standards and approvals.
Regulatory Affairs
Structured planning, smart resourcing, and precise oversight keep projects on track.
Project Management
Protecting innovation while navigating complex pharmaceutical regulations.
