Next Upcoming Seminar: Developing and Implementing SQF Systems – a Training Partnership with HACCP Consulting Group – February 6-7, 2018

Specializing in FDA Regulatory Matters

White Papers

An Overview of Drug Master Files

Prepared by Albert Yehaskel, Independent Consultant, EAS Consulting Group, LLC. January 18, 2018 Abstract 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… Read More

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

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

Compliance with EU Food Regulation: what if traceability and food recall are not enough?

Prepared by EAS Consulting Group Affiliates from Almater Food Technologists srl and Lexma Consulting, Italy March 9, 2017 Abstract EAS Consulting Group, LLC, leaders in FDA regulatory consulting is pleased to release a joint White Paper prepared by Italian business associate, Almater Food Technologists and Consultants srl (Italy) and LEXMA, who provide consulting services to… Read More

Analysis of Final FDA Regulations Establishing New Reference Amounts Customarily Consumed (RACCs), New Requirements for Single Serving Containers, and Dual Column Labeling

Prepared By Bruce Silverglade, Independent Consultant, EAS Consulting Group, LLC August 25, 2016 Abstract Disclosures on the Nutrition Facts label are based on serving sizes derived from Reference Amounts Customarily Consumed (“RACCs”) that are determined by FDA. FDA has changed its RACCs for dozens of food categories, affecting the amount of nutrients for customary servings of… Read More

FDA’s Design Control Requirements for Medical Devices

Prepared by Kaiser J Aziz, Ph.D., Independent Consultant, EAS Consulting Group, LLC July 25, 2016 Abstract FDA reviews, evaluates, verifies and validates implementation of the design control requirements described in the device premarket applications (510k/ PMA). Design control requirements play a key role from the device design prototype, manufacturing process to the finished device for user… Read More

Analysis of Final FDA Regulations Amending the Nutrition Facts Label – Focus on Added Sugars

Prepared By Bruce Silverglade, Independent Consultant, EAS Consulting Group, LLC June 22, 2016 Abstract This White Paper provides an analysis of FDA’s final regulation amending the Nutrition Facts label, focusing on FDA’s new requirement for added sugars content disclosure and disclosing a %DV for added sugars. The impacts of other provisions of the final rule related to… Read More