Regulatory Quality Business Insights™

One of key objectives with our clients is assuring efficient and effective use of business funds to implement compliance measures applicable to their business.

Regulatory Quality Business Insights, RQBI™ 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.

If you are a Chief Executive Officer, Chief Operations Officers or Managing Director of a major life sciences company, you will like to determine if improvements will be necessary or your management is on the right path.

Our Proven Methodology

Your Challenges Result-oriented Best Practices
Country-specific strategies Global Regulatory Strategy
Various Quality Systems Integrated Product Quality & Operations
Redundant processes, IT systems, tools, databases Integrated Business Services
Non-compliances (483’s, EIR), Regulatory Inspections, repeat audits Integrated compliance processes that meet regulatory requirements
Ineffective, untrained and costly resources, high turnover, low morale Resource Competency
Unique processes gained over M&A activities Standardization
Unidentified risks Risk Management / Mitigation
Outsourced services Effective Partners
Manual processes; outdated legacy systems Tools (e.g. BI, Dashboards) & Automation
High SG&A Minimal Selling, General and Administrative Expenses (SG&A)
Product Complaints, Recalls and Product Holds Product Quality
Customer Issues Customer Satisfaction