Our major clients are large pharmaceutical companies with well-defined quality systems. In order to remain current (the c in cGMP) these systems are continually being re-assessed and improved. Our experience with multiple clients means we can bring the best practices and industry standards to your organization.
Not all FDA regulated industries require a full pharmaceutical level quality system but all must comply with CFR 210/211. cGMP Consulting has developed compliant but more basic quality systems for lower risk industries such as herbal supplements; drug distributors; virtual manufacturers; and shampoo, toothpaste, and candy manufacturers who have used Active Pharmaceutical ingredients in their products.
An understanding of the regulations and how they are commonly met is the key to successful FDA and quality inspections.