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 is 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

EAS Reaches Ten Year Milestone

It is with great pride that I share EAS Consulting Group’s celebration of our milestone ten year anniversary! Never had I imagined when I retired from FDA 22 years ago that I would own and operate one of the nation’s leading consulting firms that specializes in all FDA regulatory matters. I had no clue that… Read More

GRAS Final Rule: May Result in More Rejects and/or Longer FDA Reviews

On August 17, 2016, FDA published a final rule which formally codifies the requirements for GRAS Notices that originated with the GRAS proposal published in 1997. FDA states that the expressed intent of this final rule is to “... clarify the criteria used to determine whether the use of a substance in human or animal food is generally recognized… Read More

Recent White Papers

Analysis of Final FDA Regulations Establishing New Reference Amounts Customarily Consumed (RACCs), New Requirements for Single Serving Containers, and Dual Column Labeling

Prepared By Bruce Silverglade, Expert Consultant, EAS Consulting Group, LLC August 25, 2016 Disclosures on the Nutrition Facts label are based on serving sizes derived from Reference Amounts Customarily Consumed ("RACCs") that are determined by FDA. FDA has changed its RACCs for dozens of food categories, affecting the amount of nutrients for customary servings of… Read More

Recent Blog posts

EAS Consulting Group, LLC Welcomes Domenic Veneziano as the New Independent Advisor for Import Operations

EAS Consulting Group, LLC is very pleased to welcome Domenic Veneziano as the new Independent Advisor for Import Operations. Mr. Veneziano is a veteran FDA specialist with over 24 years of Agency experience. While at FDA, he was a Captain in the US Public Health Service serving most recently as director of the FDA's Division… Read More

EAS Consulting Group Launched New Strategic Consulting Service for Food Product Development & Labeling

July 8, 2016  Media Contact: Cathryn Sacra (571) 447-5505 csacra@easconsultinggroup.com Alexandria, VA, USA – EAS Consulting Group, LLC (EAS), a leading consulting, training and auditing firm that specializes in Food and Drug Administration (FDA) regulatory matters, is now offering a new strategic consulting service to the food industry, as they struggle to develop new foods and dietary… Read More

Quality Agreements in the Complex World of Dietary Supplements

One of the most fundamental concepts in the dietary supplement regulation dictated in 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, is the role of the Quality Unit (QU).  The QU is responsible for reviewing and approving all controlled processes and documentation; as well as making all disposition… Read More