Solutions and Services | Quality & Compliance
Regulatory inspection preparation & execution
Contact us now to receive further information and an assessment from our experts. We will work with you to evaluate the best approach for your business processes.
Prepare your organization for regulatory scrutiny with confidence. Our Inspection Readiness and Mock Inspection services are designed to proactively identify compliance gaps and ensure your teams are fully prepared for official evaluations.
Comprehensive Preparation
We deliver:
- Targeted inspection preparation training
- Rigorous mock interviews
- Full GxP mock inspections
By simulating real regulatory scenarios, we help your organisation address potential issues before they arise.
Expert Guidance & Remediation
Our QA specialists work closely with your internal teams to:
- Provide actionable guidance on remediation strategies
- Deliver tailored training to strengthen compliance capabilities
- Embed a proactive culture of compliance across your organization
Proven Regulatory Experience
With extensive experience managing inspections conducted by EMA, MHRA, FDA and AIFA, our experts ensure your organization is optimally positioned to meet—and exceed—regulatory expectations.
Tailored Training Programs
We design Inspection Readiness Training that aligns seamlessly with your strategic objectives, empowering teams to:
- Anticipate regulatory challenges
- Excel in inspections
- Drive continuous improvement and risk mitigation
Our training leverages global expertise across pharmaceuticals, biotechnology, and medical devices, ensuring your organisation stays ahead of evolving standards.
Continuous Support for EU & UK Sites
For manufacturing sites across the EU and UK, clients benefit from direct access to our in-house Qualified Person, supporting compliance with all applicable regulatory requirements. Our ongoing support ensures every batch release meets the most stringent standards.
Why Choose Us?
By embedding inspection readiness into your operations, we help your organisation:
- Maintain regulatory integrity continuously
- Enhance operational excellence
- Build a resilient compliance culture
Partner with Arithmos to transform inspection readiness from a reactive task into a strategic advantage.
Consulting
- GXP Compliance Assessment
- Inspection Readiness Assessment
- Quality system, processes and organization evaluation / reorganisation including new technology enhancements (Cloud, AI, RPA)
Technology
- QMS & Quality System (and Modules):
- Design, implementation, integration (Technology agnostic approach; experience with Veeva, Agatha, SharePoint among others.)
- Migration (included “Move to Cloud”)
- Validation, with focus on User Requirements definition and System Testing
- Process automation (RPA)
- Disaster Recovery (plan & test), Business Continuity, Vulnerability management
- CAPA & Incident Management
Services
- Statutory Inspections Support, including mock inspections and CAPA management
- Inspection readiness Training
- EU and UK Qualified Person Support
Get an assessment
Contact us now to receive further information and an assessment from our experts.
We will evaluate with you the best approach for your business processes.