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
- 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
- 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