Quality Management Systems (QMS)

At our FDA consulting firm, we understand that a robust Quality Management System (QMS) is the bedrock of compliance and market success. Our team of QMS experts leverages deep industry knowledge to craft tailored solutions that align with your unique needs and regulatory requirements. For medical device manufacturers, we ensure adherence to 21 CFR Part 820 and ISO 13485, while for pharmaceutical companies, we focus on 21 CFR Part 210 and 211 compliance. We also specialize in dietary supplement cGMPs (21 CFR Part 111), food safety systems like HACCP and FSMA, and cosmetic Good Manufacturing Practices. Our proven approach integrates quality into every aspect of your operations, from design and manufacturing to distribution and post-market surveillance. With our expert guidance, you can establish a QMS that not only satisfies regulators but also drives continuous improvement, reduces costs, and enhances product quality and patient safety.