FDA Registration Services

FDA Registration Services facilitates submissions to the U.S. Food and Drug Administration, including facility registrations and product listings for various industries.

FDA Registration Services provides a streamlined process for making essential submissions to the U.S. Food and Drug Administration (FDA). This includes facility registrations, product listings, and other required notifications, ensuring compliance with federal regulations. The FDA Industry Systems (FIS) platform has been operational 24/7 since October 16, 2003, and was developed in response to the Bioterrorism Act of 2002. This initiative prioritized improved information management to safeguard the food supply, mandating the development of systems for facility registration and prior notice for imported food products. Services cover a range of FDA-regulated industries, including food, biologics, drugs, medical devices, and cosmetics. Specific modules and forms are available for Acidified/Low Acid Canned Foods (LACF), Biologics Export Certification, Export Listing, and various other certification and tracking systems. Key systems supported include the Voluntary Cosmetic Registration Program, Blood Establishment Registration, Human Cell and Tissue Establishment Registration, Drug Registration and Listing, and Medical Device Registration and Listing for firms.

About

**Who they are**
FDA Registration Services is a firm that facilitates submissions to the U.S. Food and Drug Administration. They specialize in assisting companies with their regulatory obligations.

**Expertise & scope**
* Facility registrations with the FDA
* Product listings for various industries
* Submissions to the U.S. Food and Drug Administration

**Reputation / proof points**
* Coverage: US

Additional information

FDA Registration Services focuses on streamlining the process for businesses needing to comply with U.S. Food and Drug Administration requirements. Their services are designed to handle essential regulatory tasks such as facility registration and product listing, catering to a diverse range of industries that fall under FDA oversight. The company operates with a primary focus on U.S. regulatory compliance.

Key Highlights

  • Facilitates submissions to the U.S. Food and Drug Administration. Source
    “FDA Registration Services facilitates submissions to the U.S. Food and Drug Administration, including facility registrations and product listings for various industries.”
  • Specializes in facility registrations and product listings. Source
    “FDA Registration Services facilitates submissions to the U.S. Food and Drug Administration, including facility registrations and product listings for various industries.”
  • Provides services for various industries. Source
    “FDA Registration Services facilitates submissions to the U.S. Food and Drug Administration, including facility registrations and product listings for various industries.”

Certifications & Trust Signals

  • Established provider of FDA registration and U.S. Agent services. Source
    “U.S. Agent representation and FDA registration services for foreign manufacturers.”

Buyer Snapshot

Best for
  • Companies needing FDA facility registration
  • Businesses requiring FDA product listing
How engagement typically works
  • Facilitates submissions
  • Handles regulatory tasks
Typical deliverables
  • FDA Facility Registration
  • FDA Product Listing
Good to know
  • Best when requiring assistance with U.S. FDA submissions.
HQ: United States, US
Languages: English
Timezones: EST, PST
Status: listed

Services & Capabilities

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Jurisdictions: US
Countries: US
Industries: Medical Devices, Pharmaceuticals, Biotech, IVD, Food & Beverage
Onboarding time: 3–14 days
Pricing model: Custom pricing
Registration Support: Yes
Product Type: devices

Additional us_agent_fda Details

Product Types
Medical Devices
Registration Support
Yes
Recall Support
No
Inspection Support
Yes
Emergency Contact24x7
No
US Entity State
Not specified
Onboarding Steps
Streamlined registration process
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