Next Upcoming Seminar: Developing and Implementing SQF Systems – a Training Partnership with HACCP Consulting Group – February 6-7, 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 Issue of the Month Article

Pharma’s Problems with Data Integrity

Data Integrity needs to be taken seriously in the pharmaceutical industry today and always! The FDA has issued many Warning Letters and Import Alerts to dosage form and Active Pharmaceutical Ingredient (API) manufacturers in the past several years. Manufacturers need to understand that once FDA finds some of your data to be unreliable, then they… Read More

Our Year in Review

As 2017 draws to a close, it is appropriate to reflect on a year full of change, important milestones and growth not only at FDA but also here at EAS Consulting Group. Both organizations saw new staffing and new initiatives. With the inauguration of President Trump, FDA saw a changing political dynamic with new enforcement… Read More

Recent White Papers

The Role of Regulatory Affairs in Product Development

Prepared by Neil Smith and Sandy Brand, Independent Consultants, EAS Consulting Group, LLC November 2, 2017 Abstract Regulatory Affairs touches each and every product within a company, ensuring compliance with local regulations and internal policies and the creation of sound guidelines related to labeling, safety and nutrition. Through the strategic links to trade associations, Government… Read More

Recent Announcements

EAS Consulting Group, LLC Announces New Independent Advisor for Pharmaceutical Submissions, Albert Yehaskel

December 19, 2017 Alexandria, VA For Immediate Release Contact Bryan Coleman, (571) 447-5504 EAS Consulting Group, LLC is very pleased to welcome Albert Yehaskel as the new Independent Advisor for Pharmaceutical Submissions. In this role, he will provide expert advice and guidance, while continuing to provide independent consulting to EAS clients in the development, technical… Read More

Unraveling The Impact of FSMA On Acidified Food Regulations

Do you understand the impact of the Food Safety Modernization Act (FSMA) on Acidified Foods (AF)? Do you understand the terms of AF regulations and the interplay with a modern, risk-based food safety plan? Is your food safety system for AF robust enough for an inspection by the Food and Drug Administration (FDA)? This webinar… Read More

Key Changes in SQF 8.0

While 2017 is a year for manufacturing facilities to augment their FSMA programs for US markets, 2018 will be a year to update their GFSI systems. Beginning in January SQF advances to Edition 8.0.  Learn more about these revisions and the impact on SQF 8.0 on facilities who are, or plan to be, certified by… Read More