In a highly regulated sector like healthcare, compliance with standards and best practices is vital to ensure product quality, patient safety, and business sustainability.
At Universal Medica Group, we support pharmaceutical companies, medical device manufacturers, biotech firms, and other healthcare stakeholders in managing and optimizing their quality, regulatory, and supplier audits.
Our experts operate on-site or remotely to ensure regulatory compliance, process optimization, and risk management related to the manufacturing and distribution of healthcare products.
Why Are Audits a Strategic Lever for Your Industry?
- Ensure regulatory compliance with international standards (EMA, FDA, ANSM, etc.)
- Optimize industrial process quality and enhance operational performance
- Manage risks and prevent non-compliance that could impact patient safety
- Reinforce trust with health authorities, partners, and clients
- Prepare effectively for regulatory inspections and meet certification body requirements
Our approach?
A rigorous methodology, qualified experts, and strategic recommendations to continuously improve your quality system.
Key values of our auditors:
effective, and personalized support
and trained experts, informed about updates in health authority requirements/standards
to internal and external stakeholders
availability, adaptability, and flexibility of our auditors in France and internationally
To ensure transparency, sustainability, and the long-term success of your business in the healthcare world, rely on a reliable and experienced audit service.
Our Audit Expertise for the Healthcare Industry
Our services cover a wide range of audits tailored to various life sciences sectors.
Compliance and Regulatory Audits
- Verification of compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Laboratory Practices (GLP), and Good Pharmacovigilance Practices (GVP)
- Audits for compliance with EMA, FDA, ANSM regulations
- Evaluation of compliance with ISO standards 9001, 13485, 17025, 22716
- Support for of health authority inspections and implementation of corrective actions
Case Study: support provided to a pharmaceutical company during an ANSM inspection, resulting in licence renewal with no major observations.
Supplier and Subcontractor Audits
- Assessment of best practices among manufacturers, distributors, and service providers
- Audits of production, storage, and distribution sites to ensure compliance with international standards
- Risk management related to outsourcing (compliance capability evaluation, certifications, and internal procedures)
- Supplier qualification and follow-up on non-conformities including improvement guidance
Our added value? A pragmatic approach to optimizing supplier relationships while ensuring impeccable product quality.
Internal Audits and Inspection Readiness
- Diagnosis of internal quality organization and process compliance
- Audit simulations to anticipate health authority inspections
- Team training on inspection management and regulatory requirements
- Implementation of a Business Continuity Plan (BCP) in case of major findings
Why is this crucial? Proactive preparation helps prevent penalties and improves overall company compliance.
Mutualized Audits for a Cost-Effective and Efficient Approach
- Execution of multi-client audits, helping reduce audit costs and timelines
- Resource pooling to assess the same supplier or subcontractor against a common set of criteria
Strategic advantage: Cost sharing to improve efficiency and optimize quality processes.
How does a shared audit work?
One or more auditors conduct the audit at your suppliers'/service providers' site
A single intervention instead of multiple audits
Full management of the process: planning, coordination, execution
Benefits of a shared audit:
| Supplier | Client | |
| Cost reduction (especially travel expenses) | x | X |
| Time optimization | X | x |
| Reduced redundancy | X | x |
| Streamlined communication | X | X |
Post-Audit Support and Continuous Improvement
- Drafting of detailed audit reports and strategic recommendations
- Implementation of Corrective and Preventive Action Plans (CAPA)
- Remediation support and follow-up of implemented actions
- Team training on best practices and non-compliance management
Our mission? To transform audits into a driver of sustainable improvement and performance for your organization.
Why Choose Universal Medica Group for Your Audits?
- Over 15 years of experience auditing across the healthcare and Life sciences industries
- Regulatory and quality assurance experts from leading pharmaceutical companies
- Agile methodology and personalized approach tailored to your specific activities
- Services available in France and internationally with multi-regulatory insight
- Efficient and optimized audits to ensure compliance, performance, and operational excellence
Universal Medica Group: Your Trusted Partner for High-Performance Quality Audits
An audit should not be a mere formality, but a lever for performance and continuous improvement. With Universal Medica Group, benefit from tailored support and expert insights to ensure operational compliance, optimize your processes, and enhance the safety of healthcare products.
Need an audit? Contact us today to learn how we can support you.
