Next Upcoming Webinar: Navigating the FSVP Maze: A Primer for Customs Brokers and Importers – August 24, 2017

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

Getting Your Medical Device Into the U.S. Market

If you are a manufacturer whose medical device is either a Class I, or a 510(k) exempt device Class II device, consider yourself and your company lucky that you do not have to try to “thread the needle” of the litigious and arduous process known as 510(k) clearance. Getting a device ready for 510(k) submission… Read More

Changes in What Constitutes ‘Dietary Fiber’ for Nutrition Facts Labeling May be in the Works

One of the more controversial aspects of the FDA’s final rule on revising the Nutrition Facts Panel (NFP), 81 Fed. Reg. 33742 (May 27, 2016), changes the definition of “Dietary Fiber” as it is disclosed on the NFP. The new rule requires that only certain naturally occurring dietary fibers such as those found in fruits… Read More

Recent White Papers

Compliance with EU Food Regulation: what if traceability and food recall are not enough?

Prepared by EAS Consulting Group Affiliates from Almater Food Technologists srl and Lexma Consulting, Italy March 9, 2017 Abstract EAS Consulting Group, LLC, leaders in FDA regulatory consulting is pleased to release a joint White Paper prepared by Italian business associate, Almater Food Technologists and Consultants srl (Italy) and LEXMA, who provide consulting services to… Read More

Recent Blog posts

EAS Consulting Group, LLC Announces Dr. Tara Lin Couch as New Senior Director, Dietary Supplements and Tobacco Services.

August 3, 2017, Alexandria, VA For Immediate Release Contact Cathryn Sacra, 571-447-5500 EAS Consulting Group, LLC is very pleased to announce the hiring of Tara Lin Couch, Ph.D. as Senior Director, Dietary Supplements and Tobacco Services. Dr. Couch has been an independent consultant for EAS Consulting Group since 2012 and was invited to be the EAS… Read More

Foreign Supplier Verification Program – What Does It Mean For Your Business

If you export food, food ingredients, food packaging, dietary supplements or food additives to the United States, your U.S. Importer will soon require that you provide documentation verifying that your company is compliant with the Food Safety Modernization Act (FSMA) regulations from the U.S. Food and Drug Administration (FDA). This could include compliance with a… Read More

Independent Advisor for FSMA, Charles Breen Participated in a Webinar on FSMA with AutoCoding Systems

EAS Independent Advisor for FSMA, Charles Breen participated in a recent webinar. The webinar reviewed  FSMA and the role of automation with AutoCoding Systems. Mr. Breen discussed the details of FSMA requirements. With attention to a focus on preventing food safety problems rather than reacting to problems after they occur. To watch a replay of the webinar head over to xtalks.com… Read More