EAS Consulting Group
EAS Consulting Group specializes in FDA regulatory matters, offering expert guidance and compliance solutions for industries regulated by the FDA, USDA, and supporting agencies. They provide services like consulting, submissions, auditing, and training.
EAS Consulting Group is a premier provider of regulatory compliance solutions for companies operating under FDA, USDA, and related agencies. Their team of seasoned consultants offers expert guidance across a spectrum of regulatory requirements, including consulting, submissions, auditing, and training. They are particularly adept at assisting foreign firms importing FDA-regulated products into the United States, acting as a crucial intermediary to navigate import challenges, ensure compliance, and facilitate timely market entry. This includes services such as submissions assistance, facility registrations, and handling detained products. Furthermore, EAS Consulting Group prepares foreign firms for FDA foreign inspections through "Mock-FDA" inspections and assists those found in violation to implement necessary corrections. They also offer specialized support for issues like FDA Form 483 responses, 21 CFR Part 11 compliance for electronic records, and recall assistance, aiming to prevent escalated enforcement actions and ensure adherence to the highest regulatory standards.
About
**Who they are**
EAS Consulting Group serves as the U.S. Agent for foreign firms importing FDA-regulated products into the United States. They specialize in navigating complex regulatory landscapes for industries overseen by the FDA, USDA, and supporting agencies.
**Expertise & scope**
* Acts as an intermediary between foreign firms and the FDA to facilitate product imports.
* Provides assistance with submissions, facility registrations, and handling detained products.
* Offers guidance on compliance with regulations such as the Food Safety Modernization Act (FSMA).
* Conducts mock FDA inspections and assists with remediation for violations and warning letters.
* Specializes in GRAS notifications, Food Contact Notifications (FCNs), and Food Additive Petitions.
* Provides support for product development, labeling, and certification preparation.
* Offers auditing services, including desk reviews and FSMA readiness assessments, conducted by former FDA, USDA, and state investigators.
* Keeps clients updated on FDA news, including press releases, recalls, and enforcement reports.
* Provides insights into FDA's evolving regulatory expectations, such as those related to the Modernization of Cosmetics Regulation Act (MoCRA).
**Reputation / proof points**
* Consultants include former FDA, USDA, and state investigators, laboratory personnel, and industry quality experts.
EAS Consulting Group serves as the U.S. Agent for foreign firms importing FDA-regulated products into the United States. They specialize in navigating complex regulatory landscapes for industries overseen by the FDA, USDA, and supporting agencies.
**Expertise & scope**
* Acts as an intermediary between foreign firms and the FDA to facilitate product imports.
* Provides assistance with submissions, facility registrations, and handling detained products.
* Offers guidance on compliance with regulations such as the Food Safety Modernization Act (FSMA).
* Conducts mock FDA inspections and assists with remediation for violations and warning letters.
* Specializes in GRAS notifications, Food Contact Notifications (FCNs), and Food Additive Petitions.
* Provides support for product development, labeling, and certification preparation.
* Offers auditing services, including desk reviews and FSMA readiness assessments, conducted by former FDA, USDA, and state investigators.
* Keeps clients updated on FDA news, including press releases, recalls, and enforcement reports.
* Provides insights into FDA's evolving regulatory expectations, such as those related to the Modernization of Cosmetics Regulation Act (MoCRA).
**Reputation / proof points**
* Consultants include former FDA, USDA, and state investigators, laboratory personnel, and industry quality experts.
Additional information
EAS Consulting Group assists foreign companies in overcoming import challenges, including issues with prior notice, labeling accuracy, LACF registration, and supplier qualifications under FSMA. They also help firms prepare for FDA foreign inspections by conducting mock inspections and aiding in corrective actions for identified violations. Their expertise extends to navigating specific FDA submissions like GRAS, NDI, DMF, and IDEs, ensuring timely and accurate filing of required documentation to expedite product entry into the U.S. marketplace.
Key Highlights
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Serves as the U.S. Agent for importers of FDA-regulated products.
Source
“EAS Consulting Group serves as US Agent for importers of FDA regulated products into the United States.”
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Provides expertise in GRAS, FCNs, and Food Additive Petitions.
Source
“If the GRAS option is not feasible or preferred, EAS can help you with other options, e.g., food additive petition, food contact notification (FCN), the threshold of regulation, etc.”
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Auditors include former FDA, USDA, and state investigators.
Source
“EAS auditors are former FDA, USDA and state investigators, laboratory personnel and industry quality experts who conduct GMP/Quality Systems audits of suppliers, contract manufacturing and laboratory facilities”
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Assists with compliance related to the Food Safety Modernization Act (FSMA).
Source
“supplier qualifications under the Food Safety Modernization Act (FSMA) and more. Trust EAS to ensure your firm receives the detailed assistance required.”
Certifications & Trust Signals
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Consultants include former FDA, USDA, and state investigators.
Source
“EAS auditors are former FDA, USDA and state investigators, laboratory personnel and industry quality experts”
Buyer Snapshot
Best for
- Foreign firms importing FDA-regulated products into the US.
- Companies needing assistance with FDA submissions and regulatory compliance.
How engagement typically works
- Acting as a direct intermediary with regulatory authorities.
- Providing expert consultation and problem-solving.
Typical deliverables
- US Agent services.
- FDA submission support.
- Facility registration assistance.
- Mock FDA inspections.
- Audit reports and gap assessments.
Good to know
- Best when requiring specialized expertise in FDA regulations for imported goods.
HQ:
Alexandria, US
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Foods, Dietary supplements, Cosmetics, Medical devices, Drugs
Portfolio:
26-100
Onboarding time:
1–3 days
Pricing model:
Onboarding + annual retainer
Starting from:
USD 950
Included services:
FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Annual Renewal Support:
Yes
Registration Support:
Yes
Inspection Support:
Yes
Annual Renewal Reminder:
Yes
Product Type:
devices
Service Types:
US Agent Services, FDA Registration/Listing Support, Recall Support, Inspection Support, Label Review, FDA Submissions (510(k), PMA, IDE, etc.), Regulatory Consulting, Training/Education
Additional us_agent_fda Details
Included Services Detailed
Designation support and onboarding checklist for foreign establishment U.S. Agent setup, FDA communications receipt, acknowledgment, and routing to your designated contacts, Inspection scheduling support and operational readiness escalation (when applicable), Annual registration renewal reminders and administrative coordination
Excluded Services
Acting as importer of record, Commercial distribution management, Legal representation in enforcement actions
Onboarding Steps
Intake → designate contacts → confirm scope → activate communications workflow
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
FDA regulated products (food, cosmetics, etc.)
Registration Support
Yes
Recall Support
Yes, by providing updates and news.
Inspection Support
Yes, including mock inspections and preparation.
US Entity State
US
Emergency Contact24x7
No explicit mention.
