Next Upcoming Seminar: Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar – April 4-5, 2018

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

Food Safety Modernization Act (FSMA) Consulting

EAS Consulting Group, LLC is a leading provider of food safety and regulatory services. With more than 50 years of experience assisting clients in developing regulatory compliance strategies, implementing food safety quality assurance programs, filing regulatory submissions and ensuring compliance with FDA regulations, EAS is poised to assist food firms with the significant regulatory challenges… Read More

The Role of Your US Agent

Foreign entities who operate in US FDA regulated industries must have an appointed US Agent before doing business and importing products into the US. US Agents act as an intermediary between the foreign company and FDA, assisting with two-way communication on requirements and questions such as establishment and facility registrations, product listings as well as… Read More

EAS Consulting Group Offers Specialized Strategic Service in the Area of Food Product Development and Labeling

EAS Consulting Group, LLC, a long-time leader in FDA and USDA regulatory consulting services is offering a new strategic Product Development and Labeling service which assists companies as they struggle to develop new foods, food additives, dietary ingredients, dietary supplements and food contact substances that meet the demands of government regulations and today’s health-conscious consumers… Read More

Recent Issue of the Month Article

Have a Cup of Coffee and Pray – It’s the 20th Anniversary of the Seafood HACCP Rule

HACCP, of course, stands for Hazard Analysis Critical Control Point, is a highly effective preventive control system for foods and other commodities. “Have a cup of coffee and pray” was how one skeptical USDA union official described HACCP implementation in meat and poultry processing plants when it was implemented in the early 2000’s. It is… 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