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The Experts in FDA and USDA Regulatory Matters

The Experts in FDA and USDA 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.

Food
Dietary Supplements
Dietary Supplements
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Pharmaceuticals
Pharmaceuticals
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Medical Devices
Medical Devices
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Tobacco
Tobacco
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Cosmetics
Cosmetics
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Veterinary
Veterinary
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Cannabis
Cannabis
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Seminars

Cosmetic Safety Substantiation

Cosmetic Safety Substantiation

Presented by Paula Brock, Ph.D., MCSI, EAS Senior Regulatory ConsultantFebruary 22, 2024 1:00 - 3:00 (Eastern)The Modernization of Cosmetics Regulations Act of 2022 (MoCRA) became effective in December 2023 and includes a requirement for safety substantiation. MoCRA...

Webinars

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On Demand Webinars

Reassessment of EMPs

Reassessment of EMPs

Reassessment of EMPs: Have You Identified the Correct Sampling Locations to Protect Your Product?An EAS Complimentary Webinar Presented by Rocelle Grabarek, EAS Independent ConsultantMarch 27, 2024 • 1pm (Eastern) 1.5 hoursMany of the environmental monitoring programs...

Latest News

Drug and Device May 2024

Final reminder that OMUFA facility user fees are due 1 June 2024. Per MoCRA, responsible persons are required to submit any serious adverse event reports to the FDA within 15 business days of...

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Drug and Device April 2024

FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023...

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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.

GMP Compliance Short Course

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