White Paper

EAS Independent Consultants provide in-depth regulatory expertise and authoritative reports on a variety of topic areas. These reports, or White Papers, are designed to provide an in-depth dive into various regulatory requirements and a thorough understanding of Agency expectations. We hope you find these documents valuable and welcome your questions or comments.

An Overview of Drug Master Files

Prepared by: Albert Yehaskel, Independent Advisor for Pharmaceutical Submissions

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 […]

The Role of Regulatory Affairs in Product Development

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

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 […]

Getting Your Medical Device Into the US Market

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

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 […]

Compliance With EU Food Regulation: What if Traceability and Food Recall are Not Enough?

Prepared by: Prepared by EAS Consulting Group Affiliates from Almater Food Technologists srl and Lexma Consulting, Italy

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 […]

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

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 number of nutrients for customary servings of foods that companies must list on the Nutrition Facts label. FDA has also […]

FDA’s Design Control Requirements for Medical Devices

Prepared by: Prepared by Kaiser J Aziz, Ph.D., Independent Consultant, EAS Consulting Group, LLC

FDA reviews, evaluates, verifies and validates the 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, the manufacturing process to the finished device for user needs. Design controls are an integrated set of management practices and procedures which are […]

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

Prepared by: Bruce Silverglade, Independent Consultant, EAS Consulting Group, LLC

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 record-keeping […]