One of key objectives with our clients is assuring efficient and effective use of business funds to implement compliance measures applicable to their business.
AXSource Consulting provides Regulatory Quality Business Insights, RQBI™, which will focus on your business operations using a multi-disciplinary approach to analyze your clinical, regulatory, quality and compliance needs from a cost-optimization point of view to enable continued and sustained value while maintaining compliance.
Our Proven Methodology
Major cost elements of your business
Clinical & Regulatory Strategy, Quality processes & regulatory compliance
Optimal resources, efficient processes, and IT tools to make your company more profitable
If you are a Chief Executive Officer, Chief Operations Officers or Managing Director of a major life sciences company, our Results-oriented Best Practices can help you determine if improvements will be necessary or if your management is on the right path.
Global Regulatory Strategy
Various Quality Systems
Integrated Product Quality & Operations
Redundant processes, IT systems, tools, databases
Integrated Business Services
Non-compliance (483’s, EIR), Regulatory Inspections, repeat audits
Integrated compliance processes to meet regulatory requirements
Ineffective, untrained and costly resources, high turnover, low morale
Unique processes gained over M&A activities
Manual processes; outdated legacy systems
Tools (e.g. BI, Dashboards) & Automation
High General & Administrative Expenses (SG&A)
Minimal Selling and SG&A
Product Complaints, Recalls and Product Holds