FDABasics
★★★★★
4.4
/ 5
•
92 reviews
FDABasics provides essential resources and guidance for navigating FDA regulations, helping businesses ensure compliance and market access.
FDABasics is dedicated to simplifying the complex landscape of FDA regulations for businesses. They offer comprehensive information and tools to assist with compliance, product registration, and understanding regulatory requirements. Their platform serves as a valuable resource for companies seeking to bring products to market safely and efficiently, ensuring adherence to all necessary FDA guidelines. As a provider within the us_agent_fda directory, FDABasics focuses on delivering clear, actionable insights into FDA processes. Whether you are a startup or an established enterprise, FDABasics aims to be your trusted partner in managing FDA-related challenges and opportunities.
About
**Who they are**
FDABasics provides essential resources and guidance for navigating FDA regulations, helping businesses ensure compliance and market access. With 15 years of experience, they specialize in US Agent services for foreign companies across various industries.
**Expertise & scope**
* US Agent services for medical device registration renewal, including support for updating US Agent information without additional fees.
* Assistance with FDA medical device registration and listing services for companies involved in manufacturing, testing, packing, labeling, sterilization, or import.
* Support for Pre-Market Notification 510(k) and Pre-Market Approval (PMA) for medical devices.
* US Agent services for foreign drug companies, including support for ANDA, NDA, IND, and DMF filing.
* FDA Drug Establishment Registration Services & Renewal Process, Drug Listing & NDC Number Registration Services.
* US Agent and food facility registration services for foreign food, beverage, and dietary supplement companies.
* Assistance with IND and NDA filing, Generic Drug Application (ANDA) Submission Process, and FDA DMF Filing in eCTD format.
**Reputation / proof points**
* Excellent ratings on Trustpilot and Google.
* 15 years of experience in the field.
FDABasics provides essential resources and guidance for navigating FDA regulations, helping businesses ensure compliance and market access. With 15 years of experience, they specialize in US Agent services for foreign companies across various industries.
**Expertise & scope**
* US Agent services for medical device registration renewal, including support for updating US Agent information without additional fees.
* Assistance with FDA medical device registration and listing services for companies involved in manufacturing, testing, packing, labeling, sterilization, or import.
* Support for Pre-Market Notification 510(k) and Pre-Market Approval (PMA) for medical devices.
* US Agent services for foreign drug companies, including support for ANDA, NDA, IND, and DMF filing.
* FDA Drug Establishment Registration Services & Renewal Process, Drug Listing & NDC Number Registration Services.
* US Agent and food facility registration services for foreign food, beverage, and dietary supplement companies.
* Assistance with IND and NDA filing, Generic Drug Application (ANDA) Submission Process, and FDA DMF Filing in eCTD format.
**Reputation / proof points**
* Excellent ratings on Trustpilot and Google.
* 15 years of experience in the field.
Additional information
FDABasics emphasizes transparent pricing with no hidden fees or annual hikes for their US Agent services. They offer competitive rates, with US Agent fees starting at $299 per year for food and dietary supplement companies. For drug companies, fees may be higher if potential regulatory submissions like NDA, IND, or ANDA are involved, due to the increased agent involvement required. They can complete US Agent appointment formalities online in as little as 20 minutes, providing the necessary US Agent details for regulatory submissions or registrations promptly after information submission and payment.
Key Highlights
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Offers US Agent services for medical devices, drugs, and food/dietary supplements.
Source
“We offer FDA US Agent for medical device registration renewal process.”
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Provides assistance for various FDA regulatory submissions including 510(k), PMA, NDA, IND, ANDA, and DMF filing.
Source
“We provide complete assistance for Pre-Market Notification 510(k), at highly competitive fees.”
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Emphasizes transparent pricing with no hidden fees or annual fee hikes.
Source
“Lowest fee, NO annual fee hike, and NO hidden fee.”
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Can complete US Agent appointment formalities in as little as 20 minutes.
Source
“We can complete the US Agent appointment formalities in just 20 minutes, using through our online system.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Foreign companies seeking US Agent representation for FDA compliance.
- Businesses needing assistance with FDA registration and listing services.
- Manufacturers and distributors of drugs, medical devices, and food products.
How engagement typically works
- Online appointment system for quick formalities.
- Direct communication channel for FDA correspondence.
- Support for various regulatory submission types.
Typical deliverables
- US Agent appointment and representation.
- FDA Establishment Registration and Device Listing.
- Assistance with regulatory submissions (510(k), PMA, NDA, ANDA, IND, DMF).
- Drug Listing and NDC Number Registration.
Good to know
- Best when companies require a US-based intermediary for FDA communications.
- Consideration for potentially higher fees with complex regulatory submissions.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: US Agent fees start at $299 per year for food and dietary supplements; may be higher for drug companies
Notes:
Based on publicly listed information; final fees depend on scope and services required.
“Our annual US Agent fee is $ 250 per year when you pay for two years and $ 299 when you pay for one year.”
HQ:
Orlando, 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
Portfolio:
1-5
Onboarding time:
1–10 days
Pricing model:
Custom pricing
Starting from:
USD 299
Included services:
FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Annual Renewal Support:
Yes
Registration Support:
Yes
Inspection Support:
Yes
Emergency Contact24x7:
No
Annual Renewal Reminder:
Yes
Product Type:
food
Service Types:
US Agent Services, FDA Registration/Listing Support, Inspection Support, FDA Submissions (510(k), PMA, IDE, etc.), 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
Online system for appointment formalities, requires company information and payment.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Medical Devices, Drugs, Food, Beverages, Dietary Supplements
Registration Support
Yes
Inspection Support
Yes
