The Food and Drug Administration has recently implemented two new rules that affect all medical device manufacturers, initial distributors and repackager/relabelers. The first new rule that went into effect on September 24, 2014, but up until now affected fewer than 10 percent of medical device manufactures, initial distributors and repackager/relabelers, is the Unique Device Identification… Read More
EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our prime focus is to assist domestic and foreign pharmaceutical, medical device, tobacco, food, dietary supplement, and cosmetic firms comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives, and is assisted by an extensive network of consultants with many years of FDA and industry experience.
Headquartered in Alexandria, VA with consultants and auditors located strategically throughout North America, Asia-Pacific, UK and EU, EAS Consulting Group was established as an independent company in October 2006. Prior to that, it was a division of Kendle Regulatory Affairs (formerly known as AAC Consulting Group).
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EAS Senior Consultant Charles Breen reviewed the Food Safety Modernization Act in the context of seafood in a presentation at the International Seafood Safety and Trade Conference in Kuala Lumpur, Malaysia, June 11-12, 2015. The conference focused on seafood quality and safety topics, including trade, health and environmental issues as well as product development and innovation. The… Read More
EAS Consulting Group, LLC is pleased to welcome Susan Crane as the new Senior Advisor for Over-the-Counter (OTC) Drugs and Labeling. Ms. Crane has been an EAS Senior Consultant since 2014 and has been instrumental in helping clients navigate the challenging FDA regulations pertaining to OTCs, their monographs and labeling requirements. Her addition to the senior leadership team further solidifies… Read More
EAS Consulting Group, LLC is very pleased to welcome Tara Lin Couch, Ph.D. as the new Senior Advisor for Dietary Supplements. Dr. Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought after expert on issues pertaining to Quality… Read More