FDA Solutions Group, LLC

FDA Solutions Group, LLC is a regulatory compliance company specializing in FDA registration and listing services for food, beverages, dietary supplements, medical devices, and cosmetics. They offer streamlined, cost-effective solutions to complex regulatory requirements.

FDA Solutions Group, LLC is a specialized regulatory compliance company dedicated to assisting businesses with U.S. Food and Drug Administration (FDA) registration and compliance requirements. They focus on industries including food, beverages, dietary supplements, alcoholic beverages, medical devices, and cosmetic products. Their team of regulatory compliance specialists possesses decades of FDA industry and regulatory experience, ensuring high-quality service and client satisfaction. FDA Solutions Group, LLC offers simplified and cost-effective solutions to complex regulatory requirements, providing fixed fees without hidden costs. They have developed a streamlined approach allowing clients to submit registration and listing information directly through their website at any time, from anywhere in the world.

About

**Who they are**
FDA Solutions Group, LLC is a regulatory compliance company specializing in FDA registration and listing services. They focus on providing streamlined, cost-effective solutions for complex regulatory requirements.

**Expertise & scope**
* Regulatory compliance for food, beverages, dietary supplements, alcoholic beverages, medical devices, and cosmetics.
* Expertise in FDA registration and listing services.
* Specialized focus on Foreign Food Facility Registration & U.S. Agent Service.
* Offers solutions for Domestic Food Facility Registration.
* Provides services for Domestic Medical Device Establishment Registration.

**Reputation / proof points**
* Regulatory compliance specialists with decades of FDA industry and regulatory experience.
* Commitment to maintaining a leading position in registration and listing services.
* Focus on achieving high-quality service and client satisfaction through specialized knowledge.
* Offers simplified solutions by combining industry experience with regulatory knowledge.
* Provides cost-effective solutions with fixed fees and no additional or hidden costs.

Additional information

FDA Solutions Group, LLC emphasizes a simplified approach to FDA compliance, allowing clients to connect and submit registration information directly through their website at any time. Their services are structured around fixed fees, aiming to provide transparency for strategic business decisions regarding new products and opportunities. The company highlights its team's extensive experience in both FDA industry practices and regulatory affairs, dedicating their expertise to ensure client satisfaction and high-quality service delivery. They are committed to offering cost-effective solutions tailored to the specific needs of companies operating within the food, beverage, dietary supplement, medical device, and cosmetic sectors.

Key Highlights

  • Specializes in FDA registration and listing services for food, beverages, dietary supplements, medical devices, and cosmetics. Source
    “FDA Solutions Group, LLC is a regulatory compliance company specializing in the food, beverage, dietary supplement, alcoholic beverage, medical device and cosmetic industries.”
  • Offers Foreign Food Facility Registration & U.S. Agent Service. Source
    “Foreign Food Facility Registration & U.S. Agent Service”
  • Provides cost-effective solutions with fixed fees and no additional or hidden costs. Source
    “All our services are provided at a fixed fee, without any additional or hidden costs.”

Certifications & Trust Signals

  • Regulatory compliance specialists with decades of FDA industry and regulatory experience. Source
    “Our regulatory compliance specialists have decades of FDA industry and regulatory experience.”

Buyer Snapshot

Best for
  • Companies seeking FDA registration and listing services.
  • Businesses in the food, beverage, dietary supplement, medical device, and cosmetic industries.
  • Foreign facilities requiring a U.S. Agent.
How engagement typically works
  • Direct submission of information via website.
  • Fixed fee service model.
  • Focus on streamlined and simplified processes.
Typical deliverables
  • FDA Establishment Registration.
  • U.S. Agent Services.
  • Food Facility Registration.
  • Medical Device Establishment Registration.
Good to know
  • Best when requiring specialized FDA regulatory compliance support.

Pricing

Model: Retainer
HQ: Miami, United States
Languages: English, Spanish
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, Beverages, Dietary supplements, Cosmetics
Portfolio: 6-25
Onboarding time: 2–7 days
Pricing model: Retainer
Starting from: USD 600
Included services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Annual Renewal Support: Yes
Registration Support: Yes
Annual Renewal Reminder: Yes
Product Type: food
Service Types: US Agent Services, FDA Registration/Listing Support, Product/Device Listing

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
Clients can connect and submit registration and listing information directly through the website.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
food, beverages, dietary supplements, medical devices, cosmetics, alcoholic beverages
Registration Support
Yes
US Entity State
Florida
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