White Papers
Learn From In-Depth Reports Prepared by Our Experts
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.
Roles and Responsibilities for Ensuring the Safety of Animal Food
Prepared by Johnny Braddy, DVM, MPH, DACVPM, EAS Independent ConsultantDecember 2021
Cell-Cultured Meat Products and Plant-Based Protein Analogues
An EAS Consulting Group White Paper discusses regulatory aspects and consumer trends in cell-cultured meat products and plant-based protein analogues.
As consumer acceptance …
An Overview of Drug Master Files
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 …
The Role of Regulatory Affairs in Product Development
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 …
Getting Your Medical Device Into the US Market
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)…
Compliance With EU Food Regulation: What if Traceability and Food Recall are Not Enough?
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 …
Analysis of Final FDA Regulations Establishing New Reference Amounts Customarily Consumed (RACCs), New Requirements for Single Serving Containers, and Dual Column Labeling
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 …
FDA’s Design Control Requirements for Medical Devices
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 …
Analysis Of Final FDA Regulations Amending The Nutrition Facts Label – Focus On Added Sugars
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 …