Specializing in FDA Regulatory Matters

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 North America, Asia-Pacific, UK and EU, EAS Consulting Group was established as an independent company in October 2006. Prior to that, it was a division of Kendle Regulatory Affairs (formerly known as AAC Consulting Group).

Recent Issue of the Month Articles

FDA’s New Labeling Requirements for Restaurants and Vending Machines

For more than 20 years, FDA has required full nutrition information on the labels of packaged foods. Late last year, the agency published two final rules requiring calorie and other nutrition information for foods sold in restaurants and similar retail food establishments – effective December 1, 2015 – and calorie labeling for food sold in… Read More

Corporate Culture Meets FSMA Compliance at the Intersection of Food Safety

When the FDA’s overhaul of food safety, the Food Safety Modernization Act (FSMA), is fully rolled out in 2016 it will be the largest change the U.S. food industry has seen. And yet with all the increased requirements for compliance there is one link that is not addressed and cannot be addressed by FDA, that… Read More

When the FDA Inspector Wants to Take Photographs

Managing an FDA inspection is in itself a difficult task, but what should you do when an FDA investigator wants to take photographs at your facility? Whether it is pest sightings, equipment issues, or poor employee practices, the investigator has been trained by FDA to document situations such as these with photographs which can be used… Read More

Recent Blog posts

EAS Consulting Group Appoints New Senior Advisor for New Product Development and Submissions

ALEXANDRIA, Va., July 13, 2015 - EAS Consulting Group, LLC is very pleased to welcome Nancy Chew as the new Senior Advisor for New Product Development and Submissions.  Ms. Chew has been an EAS Expert Consultant since 2009 and has been instrumental in helping EAS clients gain approvals for pharmaceutical and medical device applications.  Her addition to the senior… Read More

Press Release

John Bailey Addresses Structure/function Claims in The Rose Sheet

EAS Senior Adviser John Bailey is featured in an article titled Regulatory Roulette: Playing In Today’s Skin-Care Market A Gamble, posted online March 17 by The Rose Sheet. Recent FDA warning letters to skin-care firms raise questions about the regulatory risks companies must assume to compete effectively in the marketplace. Bailey discusses the strategic decision… Read More

Food Allergen Requirements under FSMA

by: Robert Lake, Senior Consultant While it has always been lawful to add food allergens as ingredients to human food, the Food Allergy Labeling and Consumer Protection Act (FALCPA) added section 403(w) to the Food Drug and Cosmetic Act (FD&C Act) in 2004 to specify the label declaration requirements for major food allergens. FALCPA also… Read More

Food