In the pharmaceutical and life sciences industries, quality is a fundamental requirement to ensure patient safety, regulatory compliance, and product performance.
At Universal Medica Group, we support you at every stage in establishing, strengthening, and auditing your quality systems. Our specialized experts help pharmaceutical laboratories, medical device manufacturers, and healthcare stakeholders ensure full compliance with international regulatory requirements while optimizing internal processes.
We also assist our clients in managing, improving, and supporting their teams to enhance the performance of their quality systems. Our services cover quality processes, cleaning procedures, process validation, capacity and backlog management, and deviation and shortage handling. Thanks to our expertise, healthcare companies can strengthen operational robustness, improve efficiency, and ensure long-term regulatory compliance.
Key figures
expert jobs in BPF/GMP
cumulative days
deliverable products
recurring customers
Why Is Quality Management a Strategic Priority?
- Ensure patient safety by delivering compliant and reliable products
- Comply with international standards and regulations (GMP, GDP, ISO, ICH, FDA, EMA)
- Prevent risks and non-conformities that could lead to product recalls
- Optimize traceability and process management for sustainable performance
- Prepare for audits and inspections by health authorities
Our approach? Combining regulatory rigor, industry expertise, and tailored solutions aligned with your organization’s specific needs.
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Our Quality Management Expertise
We offer a comprehensive approach to support you in implementing, improving, and auditing your quality systems.
Implementation and Improvement of Quality Management Systems (QMS)
- Deployment and optimization of quality systems in compliance with Good Practices (GMP, GDP, GLP)
- Structuring quality documentation management processes (SOPs, technical sheets, work instructions)
- Management of non-conformities, CAPAs, and change control
- Digitization and automation of quality processes
Our edge: In-depth expertise to ensure robust, sustainable quality aligned with current regulatory challenges.
Quality Audits and Regulatory Inspections
- Internal audits to assess and optimize your quality system
- Supplier and subcontractor audits to ensure compliance with quality standards
- Preparation and support for inspections by health authorities (EMA, FDA, ANSM, MHRA)
- Handling deviations and implementing corrective and preventive action plans (CAPA)
Why is this crucial? Proactive anticipation helps avoid penalties and ensures security across your operations.
Key figures
claims handled per year
of claims closed within the deadline
of claims entered and closed within 7 days
Quality Documentation and Procedure Management
- Drafting and updating quality and regulatory procedures
- Harmonization and standardization of multi-site quality processes
- Designing and implementing quality training plans for internal teams
Illustrative Example: Our experts supported a laboratory in redesigning its Quality Management System, resulting in a 30% improvement in operational efficiency.
Training and Awareness on Quality Best Practices
- Training on Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Laboratory Practices (GLP)
- Training modules on audit management, traceability, and regulatory compliance
- Raising team awareness on ISO and ICH requirements
Our EuroAcademy platform offers interactive and certified training tailored to the needs of healthcare industries.
Why Choose Universal Medica Group for Your Quality Management?
- A team of experts specialized in quality assurance and regulatory affairs
- Tailored support adapted to the needs of laboratories and manufacturers
- A proactive approach to anticipate risks and optimize quality processes
- Proven tools and methodologies to ensure an efficient and compliant QMS
- International expertise ensuring compliance across multiple markets
Universal Medica Group: Your Quality Partner for the Healthcare and Life Sciences Industry
Excellence in quality is a key success factor for any healthcare and Life Sciences company.
With Universal Medica Group, benefit from expert and personalized support to structure and improve your quality processes, ensure regulatory compliance, and optimize your organization’s performance.
Need support with quality management? Contact us today to discover our tailored solutions.
