Next Upcoming Seminar: Developing and Implementing SQF Systems – a Training Partnership with HACCP Consulting Group – February 26-27, 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

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

A Look at the Regulation of OTC Sunscreen Formulations

The process of developing and testing a sunscreen is not unusually difficult but it does require close attention to the regulations and coordination with the testing laboratory preparing the efficacy data. Sunscreens may be part of a cosmetic line and those that are intended to provide protection from incidental sun exposure during the normal day’s… 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

The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI

EAS Regulatory Intern and recent Georgetown University graduate, Rahul Vaknalli, recently published an article in the November/December 2017 issue of the prestigious Food Drug Law Institute (FDLI) Update titled “The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI”.  Click here to read more… Read More

How to Select and Qualify a Contract Laboratory

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

FDA Regulated Industry Consultant

Job Purpose/Summary  Independent Consultants for EAS Consulting Group, LLC work closely and collaboratively with members of the EAS team, our clients, as well as our other independent consultants to provide expert direction and guidance to clients based on the most current and accurate regulatory environment. Consultants are 1099 independent contractors to EAS, their integrity, professionalism… Read More