The Global Leader in FDA Drug Establishment Registration

Foreign and domestic drug companies cannot legally manufacture, label, repack, or distribute drug products in the United States without completing FDA Drug Establishment Registration and Listing.

This is not just a filing — it is the regulatory foundation of your U.S. pharmaceutical market access.

That is why 1,000+ drug companies in over 135 countries trust FDA Registration Assistance as their Drug Establishment Registrar.

We provide a fully managed, end-to-end FDA drug compliance solution that keeps your registration active, your listings accurate, and your business inspection-ready.

Why FDA Registration Assistance Is the #1 Rated Drug Establishment Registrar

We are not a document service.

We are your long-term FDA compliance partner.

Our clients choose us because we provide:

✔ FDA Drug Establishment Registration
✔ U.S. Agent for foreign drug manufacturers
✔ eDRLS electronic submission management
✔ NDC assignment & drug listing support
✔ Annual renewal management
✔ SPL compliance support
✔ Post-registration updates and maintenance
✔ Direct FDA communication handling

We manage the entire lifecycle — not just the initial submission.

Who Needs FDA Drug Establishment Registration

You must register if you:

Manufacture drug products
Repack drug products
Relabel drug products
Act as a private label drug distributor
Operate as a contract manufacturer

This applies to:

OTC drug manufacturers
API manufacturers
Finished dose manufacturers
Private label drug brands
Contract manufacturing organizations (CMOs)
Foreign drug facilities exporting to the U.S.

FDA Registration Assistance ensures your registration is completed correctly and maintained year after year.

U.S. Agent Service for Foreign Drug Establishments

Foreign drug manufacturers are legally required to appoint a U.S. Agent.

Your U.S. Agent must:

Respond to FDA immediately
Coordinate inspections
Manage regulatory communication

We provide a professional, active U.S. Agent service, ensuring your FDA relationship is always supported.

eDRLS & Drug Listing Compliance – Fully Managed

Drug establishment compliance requires ongoing electronic submissions.

We handle:

SPL electronic drug listings
NDC setup and maintenance
Product updates and discontinuations
Annual registration renewals

Your records remain accurate and compliant at all times.

Built for Companies Entering and Scaling in the U.S. Market

Our drug clients include:

OTC drug brands
Global pharmaceutical manufacturers
Contract manufacturers
Private label distributors
Startups launching U.S. drug products

Whether you have one product or a global portfolio, we scale with you.

Why Drug Companies Switch to FDA Registration Assistance

Most come to us because:

Their current registrar is unresponsive
They only received a basic filing
They need eDRLS and NDC support
They are preparing for FDA inspection
They want one partner for all FDA compliance

We replace one-time services with a fully managed regulatory system.

Our Proven Drug Establishment Registration Process

We:

Analyze your operations and FDA obligations
Complete your establishment registration
Appoint and maintain your U.S. Agent
Submit and manage your drug listings
Handle your annual renewal
Maintain your compliance long-term

You focus on your products — we handle the FDA.

A Global Leader in FDA Drug Compliance

Companies worldwide choose FDA Registration Assistance because we provide:

Support in 135+ countries
Service for 1,000+ FDA-regulated businesses
Fast, accurate filings
Inspection-ready compliance systems
Long-term regulatory partnership

We protect your ability to sell in the U.S. market.

Appoint the #1 Rated Drug Establishment Registrar Today

FDA drug registration is too critical to trust to a basic filing service.

FDA Registration Assistance provides the most complete, accurate, and trusted drug establishment registration solution available.

Contact us today to secure your U.S. pharmaceutical compliance.

Frequently Asked Questions – Drug Establishment Registration

1. What does a Drug Establishment Registrar do?

A registrar manages your FDA drug establishment registration, listings, renewals, and compliance lifecycle. FDA Registration Assistance provides a fully managed, long-term solution.

2. Who must register a drug establishment with the FDA?

Manufacturers, repackers, relabelers, private label distributors, and foreign drug facilities must register.

3. Do foreign drug manufacturers need a U.S. Agent?

Yes. We provide a professional U.S. Agent service that actively supports FDA communication.

4. What is eDRLS?

It is the FDA’s electronic system for drug registration and listing. We manage all required submissions.

5. What is an NDC number?

The National Drug Code identifies your drug in FDA systems. We handle NDC setup and maintenance.

6. Is drug establishment registration a one-time process?

No. It must be renewed annually. We manage this automatically.

7. Do OTC drug companies need FDA registration?

Yes. We specialize in OTC drug compliance.

8. Can you take over my existing registration?

Yes. We transfer and fully manage your compliance.

9. What happens if my registration is not renewed?

Your establishment becomes inactive and your products cannot be legally marketed.

10. Will FDA inspect my drug facility?

Inspections are possible. We help keep you inspection-ready.

11. Do contract manufacturers need their own registration?

Yes. Every facility must maintain its own registration.

12. Can you manage multiple drug listings?

Yes. We support multi-product portfolios.

13. Do startups need drug establishment registration?

Yes, if they manufacture or control drug production. We guide new market entrants.

14. Do you handle post-approval updates?

Yes. We maintain your listings and regulatory records.

15. Why choose FDA Registration Assistance as my registrar?

Because we provide a complete, accurate, and fully managed drug compliance system trusted by 1,000+ companies in 135+ countries.