Delivering Working Quality
GxP quality throughout the full life cycle
Get to know us
Our Lead Quality Consultants have extensive experience within GxP and/or relevant ISO-standards.
We believe quality is an integral part of every aspect in a product’s life cycle, from product design and development to clinical trials, manufacturing, marketing, and customer support, ensuring that quality is a collective effort.
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Partnering with you
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Quality Management System
- Development or improvements of QMS for compliance with GLP, GCP, GMP, GDP and/or
ISO 9001/15189 - Gap-analysis, audits and revisions
- Selection, implementation, integration and validation of EQMS
- Computerized System Validation CSV
- Computerized System Assurance CSA
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Strategic Quality Management
- Proactive Quality planning
- Alignment with business goals
- Resource optimization
- Business and operational risk management
- Continuous Improvement
- Regulatory compliance
- Training and development
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Operational Quality Assurance
- Maintaining quality standards
- Documenting, monitoring and measuring of operational processes
- Handling of Deviations, CAPA and Change Control
- Supplier and Vendor Management
- Audits
- Establishing Sponsor Oversight and Investigational Product Management
- Securing Data Integrity
- Validation, qualification and verification
Quality is not a short-term goal
but a long-term commitment
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Maintaining high-quality standards is non-negotiable in the pharmaceutical industry. QAlliance’s experts specialize in implementing robust quality assurance systems that ensure product integrity and patient safety. Our expertise helps pharmaceutical companies establish a reputation for excellence, leading to increased customer trust and market competitiveness.
Efficiency is key to profitability and growth. QAlliance’s experts can optimize processes, streamline operations, and eliminate waste, allowing pharmaceutical businesses to allocate resources more effectively. This leads to cost savings and improved overall performance.
Quality and innovation need not be at odds. QAlliance’s consultants understand how to integrate quality practices seamlessly into innovation processes. We encourage a culture of continuous improvement that fosters both creativity and adherence to quality standards, helping you stay competitive in a rapidly evolving market.
Quality is not a short-term goal but a long-term commitment. QAlliance helps pharmaceutical businesses build a culture of quality that extends beyond initial implementation. This commitment to quality fosters sustainability and resilience in the face of industry challenges.
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