Next Upcoming Webinar: What is a Scientifically Valid Method Part 3 of a 5 Part Webinar Series – October 30, 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

U.S. Dairy Industry Challenge – How Many Food Safety Plans Are Enough?

The U.S. dairy processing industry is facing a significant challenge as it moves toward compliance with the FDA Food Safety Modernization Act (FSMA). This is best captured by a conversation I had with a corporate quality assurance vice president about six months ago. When asked how many written food safety programs each of the dairy… Read More

Tips for Auditing a Contract Laboratory

Contract laboratories provide an extremely valuable and necessary service to the dietary supplement industry. The own-label distributor or manufacturer rarely has an in-house laboratory equipped with the appropriate scientific expertise to conduct all the testing required in 21 CFR 111, Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements… Read More

Recent White Papers

Getting Your Medical Device Into the US Market

Prepared by Joe Ouellette, Independent Consultant EAS Consulting Group, LLC September 26, 2017 Abstract The White Paper provides real-world and practical information directed to the manufacturer of Class II and Class III devices in navigating the Premarket Notification 510(k) clearance with insight into the various documentation required by FDA for submitting a 501(k). Getting a… Read More

Recent Blog posts

Using Analytical Instrumentation Appropriately

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR… Read More

21 CFR 111 GMP Laboratory Overview

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR… Read More

EAS Consulting Group, LLC Announces Timothy Stewart, Ph.D. as New Independent Advisor for Dietary Supplements

EAS Consulting Group, LLC is very pleased to welcome Timothy Stewart, Ph.D. as the new Independent Advisor for Dietary Supplements.  Dr. Stewart has been an Independent Consultant for EAS since 2013 and has proven to be an invaluable asset to dietary supplement clients, taking on the most challenging projects and providing sound solutions that offer a… Read More