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

Drug Master File Submissions – An Overview

(This article summarizes a White Paper on DMF submissions prepared by EAS Independent Consultant Albert Yehaskel.) Drug Master Files (DMFs) are detailed submissions to the Food and Drug Administration (FDA) that may be used to provide confidential details about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs… Read More

FDA Updates Regulations for Establishment Registration and Drug Listing

Ten years after issuing proposed rules to amend and update regulations regarding establishment registration and drug listing, FDA published the final rule on August 31, 2016. The amendments update and clarify existing regulations and implement most of those proposed in 2006, and which were subsequently mandated by legislative changes to the Food, Drug and Cosmetic Act (FD&C… Read More

Recent White Papers

An Overview of Drug Master Files

Prepared by Albert Yehaskel, Independent Consultant, EAS Consulting Group, LLC. November 15, 2016 Abstract If you are a currently hold a Drug Master File (DMF), are planning to submit a DMF or routinely reference these documents, you will want to read our new white paper prepared by DMF expert Albert Yehaskel. Through this white paper… Read More

Recent Blog posts

EAS Consulting Group, LLC is Pleased to Welcome Steve Armstrong J.D. as the new Independent Advisor for Food Law and Regulations

EAS Consulting Group, LLC, leaders in FDA regulatory consulting services welcomes Mr. Steve Armstrong J.D. to its cadre of Independent Advisors, serving as an expert in Food Law and Regulations. Mr. Armstrong will play an integral role in EAS' new Product Development and Labeling Service, a service designed to help food firms faced with decisions to… Read More

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