Regulatory And Quality Consulting, Operational Readiness Services

Cell-cultured food production is a novel technology, and the FDA is still evaluating the best way to regulate and monitor this unique food production method. As this is a new industry, the challenge is to understand and implement food regulations while using elements of pharmaceutical production and controls to promote a level of control that is required in food production without overburdening the processes with unnecessary regulatory requirements intended for pharmaceuticals.

Learn how CAI aided a manufacturing company in merging food regulations with biopharmaceutical technology, allowing for the quick conversion of a small R&D facility into a GMP-compliant facility. Further, gain insight into the solution that helped to grow and refine the company's systems and processes for larger-scale manufacturing and long-term success.