Experience Makes the Difference
New Product Development and Labeling Strategic Consulting Service
Internationally Recognized as the Labeling "Experts"
Experts in FDA and Other Domestic and Foreign Regulatory Requirements

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Next Webinar

Qualified Individuals – FDA’s Final Link in the Chain of Food Safety and Food Imports

Charles Breen and Domenic Veneziano
April 3, 2019

Next Seminar

Dietary Supplement GMP Refresher Training

Riverside, CA
(Los Angeles area)
February 5, 2019

Due Diligence
FSMA Readiness
cGMP Compliance
Mock FDA Inspections
Preparation for Certification

GRAS • NDIs • Food Contact Substance Notifications • Food and Color Additive Petitions • INDs • BLAs • ANDAs • SPL • eCTD • IDEs • 510(k)s • Food Facility Registrations • Acidified & LACF Registrations • Cosmetic Registrations • Infant Formula Notices • Establishment Registration & Product Listings • and More!

Expert Witness in Legal Cases
Experts in Consent Decrees
M&A Due Diligence Assessments
Insurance Adjudication

Government Shut Down Impacts FDA and Industry Operations

As the Government Shut Down continues, FDA recently announced that agency operations will continue to the extent permitted by law, maintaining core functions that address imminent threats to the safety of human life as well as activities funded by carryover user fee funds. FDA will continue to respond to emergencies – such as monitoring for and quickly responding to outbreaks related to foodborne illness and the flu; support high-risk food and medical product recalls when products endanger consumers and patients and pursue civil and criminal investigations as appropriate and continue screening food and medical products that are imported to the U.S.. Mission critical surveillance for significant safety concerns with medical devices and other medical products will also continue. During this period of lapsed funding, however, FDA does not have the legal authority to accept user fees assessed for FY 2019 until an FY 2019 appropriation or Continuing Resolution for the FDA is enacted. This includes regulatory submissions for FY 2019 that require a fee payment and that are submitted during the lapse period.

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, cosmetic and biologics 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 North and South America, Europe, and various Pacific Rim counties, EAS Consulting Group is a sought-after expert in regulatory matters, assisting firms with highly technical submissions such as GRAS, DMF, NDI, ANDA, 510(k) and others, as well as the development of quality systems, label reviews, structure-function claims, GMP audits, and US Agent assistance and more. In addition, EAS assists clients with remediation strategies and responding to Form 483’s, Lists of Observations, Warning Letters, and other FDA communications. EAS experts are often asked to serve as expert witnesses and are routinely asked to speak at worldwide events on technical regulatory issues. EAS is proud to have a solid reputation in the industry as the leading consulting and training firm for FDA regulatory matters.

Mission Statement

Our mission is to provide quality regulatory advice and service and to represent the best interests of our clients in an ethical, timely, and cost-efficient manner.