FDABasics
★★★★★
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
FDABasics is a Brooklyn-based FDA compliance firm serving foreign and domestic manufacturers in 100+ countries since 1995. We provide US Agent services, FDA registration, and full compliance support across all four FDA-regulated industries: food and dietary supplements, drugs, medical devices, and cosmetics. Registration is completed within 2 business days and a Certificate of Registration is included.
Additional information
FDABasics has served foreign manufacturers in 100+ countries since 1995 across food, drug, medical device, and cosmetics. We act as your US Agent, handle all FDA communications, and manage registration, renewal, and inspection coordination. Flat published fees — no surprises.
Key Highlights
- 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
Certifications & Trust Signals
- Rated excellent on Trustpilot.
- Rated excellent on Google.
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
Languages:
English
Timezones:
America/New_York
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
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
Requires company information and payment. Appointment formalities can be completed online in approximately 20 minutes.
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, for FDA establishment registration and device/drug listing.
Inspection Support
Yes, assists the FDA to schedule inspections of foreign establishments.
US Entity State
US
⚡ Instant booking available
Appoint a Vetted FDA U.S. Agent in 2 Minutes
Compare FDABasics and other vetted providers — instant pricing, no RFQ needed.
