FDABasics
Verified
★★★★★
4.8
/ 5
•
93 reviews
US FDA compliance firm since 1995. US Agent services for food, drug, device & cosmetics manufacturers in 100+ countries. 2-day turnaround. Published fees. Brooklyn, NY based.
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 is a provider of essential resources and guidance for navigating FDA regulations. They assist businesses in ensuring compliance and facilitating market access.
**Expertise & scope**
* Guidance on navigating FDA regulations
* Support for ensuring business compliance
* Assistance with market access
**Reputation / proof points**
* Coverage: US
* Languages: English
FDABasics is a provider of essential resources and guidance for navigating FDA regulations. They assist businesses in ensuring compliance and facilitating market access.
**Expertise & scope**
* Guidance on navigating FDA regulations
* Support for ensuring business compliance
* Assistance with market access
**Reputation / proof points**
* Coverage: US
* Languages: English
Additional information
FDABasics focuses on providing the foundational knowledge and tools necessary for companies to understand and adhere to FDA requirements. Their services are designed to streamline the compliance process, enabling businesses to confidently bring their products to market. They emphasize clarity and practical application of regulatory information.
Key Highlights
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Offers 15 years of experience in FDA regulatory services.
Source
“15 years of experience”
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Provides U.S. Agent services for medical devices, drugs, and food/beverage/dietary supplement companies.
Source
“We offer FDA US Agent for medical device registration renewal process.”
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Emphasizes transparent pricing with no hidden fees or annual hikes for U.S. Agent services.
Source
“Lowest fee, NO annual fee hike, and NO hidden fee.”
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Can complete U.S. Agent appointment formalities in as little as 20 minutes.
Source
“We can complete the US Agent appointment formalities in just 20 minutes”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Businesses seeking to understand and comply with FDA regulations
- Companies aiming to gain or maintain market access in the US
How engagement typically works
- Resource-based guidance
- Information provision
Typical deliverables
- Regulatory guidance documents
- Compliance resources
Good to know
- Best when requiring foundational FDA regulatory information and support for market access.
Facts
Examples & Achievements
-30+ Years of FDA Regulatory Experience, serving clients since 1995
-Clients in 100+ Countries across all four FDA-regulated industries
-5-Star Rated on Trustpilot and Google
-Food facility registration included at no extra charge with US Agent services
-No fees for listing additional devices or proprietary names
-Transparent, competitive fees with no hidden charges
-Strict client confidentiality
-US-based team in Brooklyn, NY, meeting all FDA physical presence requirements
-Clients in 100+ Countries across all four FDA-regulated industries
-5-Star Rated on Trustpilot and Google
-Food facility registration included at no extra charge with US Agent services
-No fees for listing additional devices or proprietary names
-Transparent, competitive fees with no hidden charges
-Strict client confidentiality
-US-based team in Brooklyn, NY, meeting all FDA physical presence requirements
HQ:
Brooklyn, US
Website:
fdabasics.com
Public email:
info@fdabasics.com
Phone:
716) 775-0533
Languages:
English
Timezones:
America/New_York
Access:
Verified
Claim status:
Claimed
Services & Capabilities
Find FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US, EU, UK, CH, AU, JP, BR, Global
Countries:
US
Industries:
Foods, Dietary supplements, Medical Devices, Cosmetics, Pharmaceuticals
Portfolio:
100+, 26-100, 6-25, 1-5
Response SLA:
48 hours
Onboarding time:
1–2 days
Pricing model:
Custom pricing
Starting from:
USD 299
Included services:
FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders, Annual report
Product Type:
food, devices, drugs, cosmetics
Annual Renewal Support:
Yes
Registration Support:
Yes
Recall Support:
Yes
Time Zone Coverage:
US Eastern, US Central, US Mountain, US Pacific
Inspection Support:
Yes
Emergency Contact24x7:
Yes
Annual Renewal Reminder:
Yes
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