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 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.

Recent Issue of the Month Article

Expect More Food Labeling Changes Now FDA has Finalized Its Nutrition Facts Regulations

FDA issued its final Nutrition Facts and Serving Size regulations last month, which in part were based on the new U.S. Dietary Guidelines for Americans (2015-2020). However, those actions will not mark the end of new food labeling regulations issued by the agency. The food industry should brace itself for still more regulations that will align FDA’s nutrient content claims… Read More

Recent White Papers

Analysis of Final FDA Regulations Amending the Nutrition Facts Label – Focus on Added Sugars

Prepared By Bruce Silverglade, Expert Consultant, EAS Consulting Group, LLC June 22, 2016 This White Paper provides an analysis of FDA’s final regulation amending the Nutrition Facts label, focusing on FDA’s new requirement for added sugars content disclosure and disclosing a %DV for added sugars. The impacts of other provisions of the final rule related to… Read More

Recent Blog posts

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

How to Successfully Respond to FDA 483s and Warning Letters

EAS Senior Advisor for Quality and Compliance, Mr. Robert Fish, will present a webinar on How to Respond to FDA 483s and Warning Letters. He will discuss the correct and incorrect way to prepare these responses with emphasis on the FDA’s expectations. He will also explain why companies may receive an FDA 483 and how… Read More