The Food and Drug Administration monitors the safety of drug products marketed in the United and requires the pharmaceutical industry to document and, as applicable, report adverse events experienced by consumers when using their products. Documenting of adverse events has always been part of the record-keeping requirements of the Good Manufacturing Practices (GMP) regulations related… 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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January 12, 2016 For Immediate Release Media Contact: Cathryn Sacra (571) 447-5500 Alexandria, VA: EAS Consulting Group, LLC., (EAS) is pleased to announce that it has entered into an agreement to continue to provide regulatory services to Phoenix Regulatory Associates, Ltd., clients upon the closure of Phoenix after nearly a quarter century of operation. “Phoenix… Read More
If you are a drug manufacturer or private label distributor, you have likely had a question about FDA Establishment Registrations, National Drug Code (NDC) numbers and product listings. They can be confusing concepts! Who needs them, how do you get them, what do the various parts of the codes (labeler/product/package), mean and who is actually… Read More
EAS Senior Advisor for Dietary Supplements Tara Lin Couch, Ph.D. appears in a video clip on GMPs prepared by The Natural Products Insider from an interview at the Rocky Mountain Dietary Supplement Forum, September 24-25, 2015. Dr. Couch is an organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in… Read More