Our services include assistance with labeling and claims, preparation of highly technical submissions, overview and preparation of requirement documents and procedures such as Standard Operating Procedures (SOPs), Good Manufacturing Practice (GMPs), Response to FDA 483s and Warning Letters, remediation and consent decrees, recall assistance, US Agent services and more.
We serve the industries of Food (including USDA), Pharmaceutical, Dietary Supplements, Medical Device, Tobacco, Biologics, Cannabis, and Cosmetics. In addition, we also provide regulatory support for law firms including expert witness services, as well as insurance firms as part of a mergers and acquisitions due diligence review.
Whether the question is safety, contract manufacturer compliance, quality systems, or FSMA challenges, EAS has experts to help. Our team of labeling experts; scientists with medical, nutrition, chemistry, microbiology, and toxicology backgrounds; and compliance officials with detailed knowledge of federal/state regulations as well as import requirements and compliance procedures will provide the expert guidance you need for important regulatory requirements.
We invite you to view our services, join us in an upcoming training seminar, webinar and on-demand webinar where you will receive the latest compliance information. If you would like additional information or discuss how EAS can help your firm please contact us!