In 1998, FDA changes to the GMP became effective. The GMP now, also known as the Quality System Requirements (QSR), more closely reflects the ISO 9000 standards. Since 1978, we have worked with companies to establish quality systems that meet the FDA GMP requirements. We work closely with your staff to set up a customized

quality system to meet FDA requirements. We then train your staff in how to implement and maintain the program. We would also be available prior to and during FDA inspections of your operations to assure that the FDA inspection goes well. Replies to the FDA 483 and Warning Letters is a specialty of ours that has provided companies the necessary expertise to prevent additional regulatory actions by the agency against the company and/or it's products.