Quality & Compliance
at Eirgen Pharma
Driving excellence in regulatory compliance and quality
At Eirgen Pharma, quality is a commitment. As a trusted partner in drug development, delivery, and supply for global pharmaceutical industries, we ensure the highest regulatory compliance and quality management levels across every stage of our operations. ​
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Our mission is to improve patients' lives by delivering safe, effective, high-quality medicines. We achieve this through a robust Quality Management System (QMS), a culture of continuous improvement, and a proactive approach to regulatory engagement.
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Our Approach to Quality & Compliance
Global Standards, Local Excellence​
Eirgen Pharma operates with a comprehensive Quality Assurance and Regulatory Compliance strategy that aligns with international standards and is tailored to meet the specific needs of our partners and patients. Our systems are continuously reviewed by internal audit teams, regulatory authorities, and our customers to ensure ongoing compliance and excellence.
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Inspection- Ready, Always​
With a disciplined operational framework and a culture of accountability, our facilities are maintained in a state of constant inspection readiness. We welcome regular audits and inspections as opportunities to demonstrate our commitment to quality and to learn and improve.
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How We Deliver Quality
Quality Compliance Maturity​​
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Corporate quality policies cascade into site-specific SOPs to ensure consistency and compliance.
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Continuous feedback loops with customers and regulators drive improvements.
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Centralized tracking of regulatory intelligence, inspection outcomes, and corrective actions. ​
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Monthly regulatory updates shared across leadership to ensure alignment and awareness.
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Operational Excellence​​
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Senior leadership engagement through weekly, monthly, and quarterly quality reviews. ​
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Dedicated internal QA teams ensure compliance with internal, customer, and regulatory expectations.
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Global systems for managing deviation, CAPAs, complaints, and supplier quality.
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Transparent communication of performance metrics and improvement initiatives with partners.
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Organizational Vitality​​
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Comprehensive GMP training for all employees.
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Cross-functional best practice forums to foster innovation and continuous improvement.
Our Quality Culture
At Eirgen Pharma, quality is everyone's responsibility. From the production floor to executive leadership, we foster a culture where quality and compliance are embedded in every decision and action we make. Our teams are empowered to speak up, share insights, and drive improvements that benefit our partners, and ultimately, improve the lives of our patients. ​
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Transparency & Collaboration
We believe in building strong, transparent relationships with our partners. Regular joint reviews, updates, and collaborative inspections ensures alignment and fosters trust. Our proactive communication with regulatory bodies and industry groups helps shape the future of pharmaceutical quality standards.
Eirgen Pharma Quality Policy
We are committed to;
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Placing patients at the center of our decisions
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Ensuring full compliance with all applicable laws, regulations, and industry standards.
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Maintaining data integrity and transparency across all operations.
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Driving continuous improvement through disciplined execution and accountability.
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Empowering our people through training, engagement, and a shared commitment to excellence.
