An FDA drug inspection can be a very stressful experience. If it is a pre-approval inspection there is a lot at stake concerning the outcome. If the company does not pass, the application (NDA/ANDA) may not be approved or the approval may be significantly delayed. But with proper preparation the stress level can be significantly… Read More
EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our prime focus is to assist domestic and foreign pharmaceutical, medical device, tobacco, food, dietary supplement, and cosmetic firms comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives, and is assisted by an extensive network of consultants with many years of FDA and industry experience.
Headquartered in Alexandria, VA with consultants and auditors located strategically throughout the U.S., Europe and Asia, EAS Consulting Group is a sought after expert in regulatory matters, assisting firms with highly technical submissions from GRAS, DMF, NDI, ANDA, 510(k) and others, to label reviews, structure function claims, GMP audits, US Agent assistance and to serve as expert witnesses. EAS consultants are routinely asked to speak at worldwide events on regulatory issues and is EAS is proud to have a solid reputation in the industry as the leading consulting and training firm for FDA regulatory matters.
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With FDA inspections becoming more frequent, particularly in the dietary supplement world, it is imperative that companies familiarize themselves with how to host and manage such an inspection. We say “manage an FDA inspection” because the more knowledge a company has the better able it will be to make the inspection process move smoothly in… Read More
The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses begin in September 2016. The final FSMA rules are available in pre-published form - FSMA Final Rules. The Food and Drug Administration (FDA or we) is amending our regulation for Current Good Manufacturing Practice… Read More
FDA has published a notice in the Federal Register extending until October 13, 2015, the comment period on its proposed changes to the Nutrition Facts and Supplement Facts panels used in labeling conventional foods and dietary supplements… Read More