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 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 consultants are routinely asked to speak at worldwide events on regulatory issues and is 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

The Purpose of a DEA Regulatory Investigation

Everyone has read recent newspaper and internet stories about the rise in heroin abuse and its relationship with pharmaceutical opiates that were originally prescribed for legitimate medical reasons. Unfortunately, this problem has been around since the Civil War when morphine was given to soldiers for horrific injuries, and the soldiers became dependent on that narcotic… Read More

Recent Blog posts

Time is running out to for the Early Bird discounted rate for FSPCA Preventive Controls for Human Food Course

EAS and the HACCP Consulting Group will present a course on compliance with FDA’s final rule on Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation. The regulation requires that certain activities be completed by a "preventive controls qualified individual" who has "successfully completed training in the development and application of risk-based preventive controls."… Read More

EAS Consulting Group Enters Into an Asset Purchase Agreement with Phoenix Regulatory Associates

January 12, 2016 For Immediate Release Media Contact: Cathryn Sacra (571) 447-5500 Alexandria, VA: EAS Consulting Group, LLC., (EAS) is pleased to announce that it has entered into an agreement to continue to provide regulatory services to Phoenix Regulatory Associates, Ltd., clients upon the closure of Phoenix after nearly a quarter century of operation. “Phoenix… Read More

Drug Establishment Registration, NDC Numbers and Product Listings – Webinar Replay

If you are a drug manufacturer or private label distributor, you have likely had a question about FDA Establishment Registrations, National Drug Code (NDC) numbers and product listings. They can be confusing concepts! Who needs them, how do you get them, what do the various parts of the codes (labeler/product/package), mean and who is actually… Read More