Stay ahead of inspections with Arithmos QA Consultancy.
The Challenge:
The pharmaceutical and life sciences industry is experiencing an uptake in FDA activities across the EU, driven by developments like the Mutual Recognition Agreement (MRA) between the FDA and EU regulators, as well as heightened oversight of compliance practices. These changes make robust inspection readiness more critical than ever.
Are your systems ready to meet these growing demands?
Introducing Arithmos QA Consultancy Services
Inspection Readiness Expertise at Its Best
Arithmos offers comprehensive services designed to ensure compliance across the life sciences industry. Our team of auditors includes subject matter experts (SMEs) across all GxPs (including: GCP, GMP, GLP, GCLP, GVP), alongside specialists in technology and computerized system lifecycles, aligned with ISPE GAMP5® standards. Using a modern, risk-based approach, we provide the evidence you need to demonstrate compliance—ensuring your organization remains audit-ready and future-proof.
How Arithmos Ensures Inspection Readiness
- Tailored Consultancy
Our experienced auditors deliver customized consultancy services tailored to your unique business, QA, and IT compliance requirements. - GAP Analysis
Identifying and addressing compliance gaps is critical. Arithmos conducts thorough, objective reviews of your processes and systems to pinpoint areas needing improvement. - Mock Inspections
Regulatory inspections can be high-pressure events. Our mock inspections simulate the real experience, preparing your team and systems to perform efficiently and confidently. - CAPA Plan
We provide actionable Corrective and Preventive Action (CAPA) plans to resolve compliance gaps and strengthen your systems. - Sustainable Results
Arithmos doesn’t just prepare you for today; we ensure your compliance processes can adapt to emerging technologies and evolving regulatory requirements.
Why Act Now?
As FDA scrutiny increases across the EU, maintaining compliance is not just a necessity—it’s a strategic advantage. By partnering with Arithmos QA Consultancy, you can:
- Stay ahead of regulatory changes.
- Streamline validation for high-frequency application releases.
- Minimize risks while ensuring operational excellence.
💡Don’t wait for an inspection to expose gaps—partner with Arithmos QA Consultancy Services today.
📩 Contact us now to book your consultation and turn inspection readiness into your competitive edge.
About the Author
Michelle Anderson
GLP Auditor
After many years of experience working in a variety of laboratories both in academia and for CRO’s, Michelle Anderson was the Quality Assurance Manager for a CRO, in which she managed all aspects of the Quality Management System, ensuring regulatory compliance of ISO 9001:2015, conducting internal and external audits as well as managing customer complaints and problem solving.
Before joining Arithmos’ UK Quality Assurance Team as GLP Auditor, Michelle was a GLP Auditor for a global life sciences and healthcare company.
About Arithmos
With deep expertise in the Life Science Industry, Arithmos supports companies in their digital transformation journey to achieve the best value from technology-enabled solutions and excellence in business operations.
Arithmos team share extensive knowledge of the full GxP regulated environment for both deliveries of services and technologies, and our domains range from Clinical R&D, Quality Assurance, Drug Safety & Pharmacovigilance, Regulatory and Medical Affairs.
