QMS analysis, design implementation & maintenance

At Arithmos, we help Life Sciences organisations design, implement, and maintain robust Quality Management Systems (QMS) that meet both local and international regulatory standards.

• Regulatory Compliance
  Fully aligned with EMA, MHRA, FDA, and AIFA requirements for CROs.
• QMS Design & Implementation
  From gap analysis and process mapping to policy development and system validation, we create practical, scalable frameworks tailored to your organisation.
• Ongoing Maintenance & Readiness
  We ensure your QMS remains inspection-ready, compliant, and continuously optimised.
• Quality Assurance Consulting
  Our experts integrate seamlessly with your teams, providing risk management, process evaluations, and strategic guidance to drive operational excellence.
• Training & Culture of Quality
  Customized training programs aligned FDA with EMA, MHRA, and AIFA standards foster a strong culture of quality and continuous improvement.
• Qualified Person (QP) Services
  In-house QP support for certification, MIA consultancy, and batch record review — on-site or remote — ensuring compliance and smooth product release.

With deep GxP expertise and a global track record, Arithmos empowers your organisation to achieve compliance, safeguard patient safety, and sustain excellence in quality assurance.