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Case Study: Leveraging QMS and Regulatory Expertise to Support Tissue Compliance

How one client navigated FDA regulatory pathways while minimizing cost and reducing time to market

the situation

The Situation

A small group of research scientists developed a novel HCT/P using cancellous bone. They sought outside Quality Management System (QMS) and Regulatory expertise to bring this product to market while managing costs. Their challenges included:

  • Keeping direct headcount and infrastructure to a minimum while having access to best practice systems, processes and people on an “as needed” basis
  • Regulatory pathway for tissue product lacked a clear path to approval
  • Time and investment was over the provided budget
  • Internal lack of experience in regulated industry; preferring to focus their time on the science
  • Lack of experience with a QMS and writing SOPs
the solution

The Solution

  • Developed and executed a regulatory strategy
  • Deployed a full suite of outsourcing products to provide QA processes and infrastructure ensuring compliance with minimum financial investment
  • Prepared the entire QMS
  • Provided training and support for client’s FDA inspections
the results

The Results

  • Simplified FDA regulatory pathway for the tissue product
  • Minimized cost, infrastructure, headcount, and time to market
  • Increased confidence in QMS, since it was developed by experienced regulatory professionals