Food Labeling Compliance Seminar – May 29-30, 2018 in Alexandria, VA

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 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 Announcements

EAS Independent Advisor for Food Law and Regulation, Steve Armstrong, Winner of 2018 Service to FDLI Award

EAS is pleased to announce that Independent Advisor for Food Law and Regulation, Steve Armstrong, is the winner of the 2018 Food Drug Law Institute’s Service to FDLI Award. Mr. Armstrong, the former Chief Law Council for the Campbell Soup Company, joined EAS as an Independent Advisor in 2016 and has been instrumental in assisting… Read More

FDA Working on Foundational Rules and Guidances

April 19, 2018

At TMAs 103rd Annual Meeting held on Tuesday, April 10, 2018, CTP Director Dr. Mitch Zeller confirmed that FDA is actively working on a number of priorities that he called “Foundational Rules and Guidances”.  This includes the issuing of the Tobacco Product Manufacturing Practice (TPMP) Rule. Read more about this announcement here. EAS offers a… Read More

FDA CTP Announces Update to Provisional Substantial Equivalence Review Process

April 10, 2018

EAS Consulting Group would like to bring to your attention an FDA Center for Tobacco Products announcement regarding updates to the Provisional Substantial Equivalence review process. Substantial equivalence (SE) is the most commonly used pathway by which tobacco products may obtain premarket authorization. Whether SE reports were submitted Provisionally, (products introduced into commercial distribution between… Read More

Recent Issue of the Month Article

Clean Label, the Challenges

So, you decided to have clean labels for your products, now what do you do? You are not alone in your pursuits of this endeavor. A couple of years ago, I was approached by a marketing department when they wanted to make certain claims in their product lines and one of the phrases they used… Read More

Recent White Papers

An Overview of Drug Master Files

Prepared by Albert Yehaskel, Independent Consultant, EAS Consulting Group, LLC.

DMFs are regulatory submissions to FDA for drug substances, drug products, and/or container closures allowing FDA to review information such as confidential details about facilities, processes, components, or articles used in the manufacturing, processing, packaging, and storing of one or more APIs and/or human drugs.  DMFs are at the discretion of the DMF holder and… Read More