Next Upcoming Seminar: Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar – April 4-5, 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

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

The Role of Regulatory Affairs in Product Development

Prepared by Neil Smith and Sandy Brand, Independent Consultants, EAS Consulting Group, LLC

November 2, 2017

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 agencies, and NGO’s the business is kept abreast of all changes in regulations that may affect the… Read More

Getting Your Medical Device Into the US Market

Prepared by Joe Ouellette, Independent Consultant EAS Consulting Group, LLC

September 26, 2017

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 device ready for 510(k) submission is can be time-consuming, costly, full of challenges and… 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

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 food firms wish to comply with EU directives and/or individual European country food laws as well as for European… 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

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 foods that companies must list on the Nutrition Facts label. FDA has also… 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

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 needs. Design controls are an integrated set of management practices and procedures which are applied… 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

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 the new added sugars disclosure are discussed as well. In addition, FDA’s new… Read More