Next Upcoming Seminar: Good Manufacturing Practice (GMP) Compliance Short Course – February 22, 2018 & March 1, 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 Announcements

EAS Consulting Group Offers Specialized Strategic Service in the Area of Food Product Development and Labeling

EAS Consulting Group, LLC, a long-time leader in FDA and USDA regulatory consulting services is offering a new strategic Product Development and Labeling service which assists companies as they struggle to develop new foods, food additives, dietary ingredients, dietary supplements and food contact substances that meet the demands of government regulations and today’s health-conscious consumers… Read More

RTAs for 510(k)s – FDA’s Newest Guidance Document Clarifies Reviews of Medical Devices

Bryan J. Coleman, Senior Director, Pharmaceuticals and Medical Devices.  FDA’s Refuse to Accept Policy for 510(k)s released January 30, 2018 laid out specific procedures the agency must follow when reviewing 510(k) submissions to assess whether the application meets a minimum threshold of acceptability so that it can move forward to a substantive review. FDA has… Read More

Food Product Development & Labeling Strategic Consulting

EAS offers strategic consulting and proactive solutions in the area of Product Development and Labeling. This unique service considers a company’s marketing objectives and the current regulatory, compliance, and enforcement environment at the federal, state and local levels. From competitive challenges – use of certain claims such as “non-GMO”, “natural” and “handcrafted” to FDA vs… Read More

Recent Issue of the Month Article

FDA’S Policy on Medical Foods

“Medical food” is a commonly misunderstood term as it is used on FDA regulated products. Many manufacturers want to market their products as medical foods because medical foods are exempt from the disease statement limitations for health and structure/function claims and are allowed to name the diseased population for whom they are designed. The following… Read More

Recent White Papers

An Overview of Drug Master Files

Prepared by Albert Yehaskel, Independent Consultant, EAS Consulting Group, LLC.

DMFs are regulatory submissions to FDA for drug substances, drug products, and/or container closures allowing FDA to review information such as confidential details about facilities, processes, components, or articles used in the manufacturing, processing, packaging, and storing of one or more APIs and/or human drugs.  DMFs are at the discretion of the DMF holder and… Read More