(571) 447-5500

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.

Food Industry Control and Protection Against COVID-19

Food Industry Control and Protection Against COVID-19

The COVID 19 Pandemic has forced the food industry to alter some of its operations in order to maintain a safe environment for its employees and customers. Urgent attention must be given to ensure compliance with measures that protect food workers from …

read more
An Overview of Drug Master Files

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 …

read more
The Role of Regulatory Affairs in Product Development

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 …

read more
Getting Your Medical Device Into the US Market

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)…

read more
FDA’s Design Control Requirements for Medical Devices

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 …

read more