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|Manual processes; outdated legacy systems||Tools (e.g. BI, Dashboards) & Automation|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|