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The Experts in FDA Regulatory Matters

EAS Consulting Group is a leading provider of regulatory compliance solutions to industries regulated by FDA, USDA, and supporting agencies. Our team of consultants provide expert guidance for all of your regulatory requirements.

Dietary Supplements
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Pharmaceuticals
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Medical Devices
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Tobacco
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Cosmetics
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Veterinary
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Cannabis
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Seminars

Preparing for an FDA CTP PMTA Pre-Approval Inspection

Preparing for an FDA CTP PMTA Pre-Approval Inspection

Join EAS Consulting Group’s Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. and EAS Independent Consultant, Charlotte Peyton, for a comprehensive look at preparing for FDA’s PMTA pre-approval inspections. July 14, 2021 from 12pm-4pm eastern.

Webinars

PMTA Deficiency Letter Readiness and Response Preparation

PMTA Deficiency Letter Readiness and Response Preparation

Part 2 of a special series focusing on CTP’s requirement of PMTA submissions With Willie J. McKinney, Ph.D., Scientific Advisor for Labstat International and CEO and Founder of McKinney Regulatory Science Advisors, LLC & Moderated by Michael Bond, President of...

On Demand Webinars

Medical Device or a Wellness Device?

Medical Device or a Wellness Device?

Wellness devices are big business, creating an accountability partner for the user and providing real-time data to their medical provider. But where does a wellness device cross the line to a medical device and what does that mean for the manufacturer? From design, to claims to special

COVID-19 Updates

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 …

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Food Labeling Challenges in a Pandemic

Under normal circumstances, food producers have many plates to spin in order to comply with food regulations, including food labeling requirements. Most especially, in order to assure accurate food ingredient, allergen and nutrition labeling, manufacturers must be certain they possess the most recent …

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Latest News

Medical Device or a Wellness Device?

Wellness devices are big business, creating an accountability partner for the user and providing real-time data to their medical provider. But where does a wellness device cross the line to a medical device and what does that mean for the manufacturer? From design, to claims to special

read more

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EAS – Your Dedicated Consultant for FSVP Services

EAS offers comprehensive services related to FSMA’s FSVP program for both foods and dietary supplements. We can even act as your Qualified Individual. For more information about our services, watch our short video.

Dietary Supplement Good Manufacturing Practice Compliance Short Course

The GMPs dictated in 21 CFR 111 have been in place for over a decade, but the FDA continues to issue numerous Warning Letters for a failure to comply with even the basic tenets of the regulation. EAS Consulting Group’s two-part short course covers the basics of working in a GMP environment including personal hygiene, sanitation, the use of SOPs, and Good Documentation Practices (GDPs). It also addresses the top 5 observations cited in FDA Warning Letters since 2010 which are Specifications, Master Manufacturing and Batch Production Records, Quality Unit responsibilities, Product Complaints, and Holding and Distribution Operations.

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