Specializing in FDA Regulatory Matters

Next Upcoming Seminar: FDA Nutrition Labeling Facts and Impacts on Food Label Claims – July 13, 2017

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 independent 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 independent consultants are routinely asked to speak at worldwide events on regulatory issues and EAS is proud to have a solid reputation in the industry as the leading consulting and training firm for FDA regulatory matters.

Recent Issue of the Month Article

Process Labeling – Pathway to Transparency?

A thirty-year old federal court opinion that is well known to students of food and drug law holds that in the absence of a detailed, Congressionally mandated definition, courts and regulators should follow the common understanding of “food” as an article that delivers “taste, aroma and nutrition.” In the 21st century, however, food not only… Read More

EAS Offers U.S. Agent Services for Foreign Companies

The FDA’s regulatory requirement for foreign firms to have a U.S. Agent can be confusing, to say the least. There are very specific requirements for foreign firms to have a U.S. Agent, and failure to have a competent and responsive U.S. Agent can cause significant compliance issues, delays in applications and submissions and can even… Read More

Recent White Papers

Compliance with EU Food Regulation: what if traceability and food recall are not enough?

Prepared by EAS Consulting Group Affiliates from Almater Food Technologists srl and Lexma Consulting, Italy March 9, 2017 Abstract EAS Consulting Group, LLC, leaders in FDA regulatory consulting is pleased to release a joint White Paper prepared by Italian business associate, Almater Food Technologists and Consultants srl (Italy) and LEXMA, who provide consulting services to… Read More

Recent Blog posts

Foreign Supplier Verification Program – What Does It Mean For Your Business

If you export food, food ingredients, food packaging, dietary supplements or food additives to the United States, your U.S. Importer will soon require that you provide documentation verifying that your company is compliant with the Food Safety Modernization Act (FSMA) regulations from the U.S. Food and Drug Administration (FDA). This could include compliance with a… Read More

Independent Advisor for FSMA, Charles Breen Participated in a Webinar on FSMA with AutoCoding Systems

EAS Independent Advisor for FSMA, Charles Breen participated in a recent webinar. The webinar reviewed  FSMA and the role of automation with AutoCoding Systems. Mr. Breen discussed the details of FSMA requirements. With attention to a focus on preventing food safety problems rather than reacting to problems after they occur. To watch a replay of the webinar head over to xtalks.com… Read More

EAS Consulting Group, LLC is Very Pleased to Welcome Allen Sayler as the New Senior Director for Food and Cosmetic Consulting Services

EAS Consulting Group, LLC is pleased to welcome long time Independent Consultant, Allen Sayler as new Senior Director for Food and Cosmetic Consulting Services.  Mr. Sayler has been an independent consultant for EAS since 2012.  In that time, his expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, food… Read More