Food Labeling Compliance Seminar – September 24-25, 2018 in Kansas City, MO

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 Issue of the Month Article

FDA 483 Responses – Missing the Mark?

In recent months, it appears more companies are having difficulties meeting the requirements of FDA Form 483, List of Observations, response. The inspection situation is very stressful and if it ends with the dreaded “483”, it can be positively overwhelming. However, when the initial reaction is over, it’s time to rally the staff and prepare… Read More

Recent Announcements

Quality Systems for the Cannabis Industry – Preparing for State GMP Regulations

As states begin to regulate legalized cannabis, the concern of how Good Manufacturing Practices (GMPs) apply to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures… Read More

Foreign Supplier Verification Program – What Does it Mean for You?

Conferencia web de EAS: Programa de verificación de proveedores extranjeros – ¿qué significa para usted? En Espanol Si usted exporta alimentos, ingredientes, empaques, suplementos o aditivos alimenticios hacia los Estados Unidos, su agente aduanal en los Estados Unidos, importador y clientes le pedirán proporcionar documentación para verificar que su empresa cumple con la Ley de… Read More

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

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