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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.

EAS Food Industry Services

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dietary supplements

Dietary Supplements

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pharmaceuticals

Pharmaceuticals

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EAS Medical Devices Services

Medical Devices

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EAS Tobacco Services

Tobacco

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cosmetics

Cosmetics

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EAS Veterinary Services

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EAS Cannabis Services

Cannabis

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Seminars

Transition from Computer System Validation (CSV) to Computer Software Assurance (CSA)

Transition from Computer System Validation (CSV) to Computer Software Assurance (CSA)

The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA. In addition, we’ve seen a trend toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations such as use of Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT that have more recently begun to be used more heavily in life science companies.

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Webinars

Animal Food GRAS: Unpacking the Essentials

Animal Food GRAS: Unpacking the Essentials

Presented by Dr. Adam Orr and Tim LombardoJune 17, 2026 | 3:00 PM ETThe U.S. is one of the most promising and expansive markets for innovative animal food ingredients. However, accessing the US requires knowledge about its regulatory requirements. Among the regulatory...

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On Demand Webinars

Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: What Industry Needs to Know

Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: What Industry Needs to Know

When the FDA issues a Form 483 at the conclusion of a drug CGMP inspection, your response becomes a defining regulatory moment. How you address these observations can directly influence outcomes, including the risk of Warning Letters or further enforcement action. In 2026, the FDA released new draft guidance titled “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” This will include a focused review of that guidance, breaking down key expectations and what they mean for industry.

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Latest News

FDA Updates Biosimilar Q&A Draft Guidance

FDA has released updated draft guidance on biosimilar development, clarifying how sponsors can use non-U.S.-licensed comparator products to support biosimilarity and what is required during FDA review.

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