Represented. Registered.
Ready to Market
Selling or exporting drug products to the US hinges on critical FDA Drug Establishment Registration and a designated US Agent—requirements that persist even post-approval. Don’t navigate this complex landscape alone. Registrar Corp streamlines compliance with expert registration and US Agent services, keeping your facility and products audit-ready for the US market.
3,000+ Drug Manufacturers Trust Registrar Corp
What Drug Products Must Register to Enter the US?
Foreign manufacturers, API suppliers, contract packagers, and repackers that produce or handle drug products for the US market are required by the FDA to register their establishments and appoint a US Agent. This mandate applies across a broad spectrum of drug categories, including:
Prescription Drugs
Homeopathic Medicines
Over-the-Counter (OTC) Drugs
Veterinary Drugs
Generic Drugs
Bulk Drug Substance
Active Pharmaceutical Ingredients (APIs)
Drugs for further processing
Without valid FDA drug establishment registration and an authorized US Agent, these products cannot be legally imported, marketed, or distributed in the United States.
Our Proven Process for FDA Drug Establishment Registration
Complying with FDA requirements involves more than filling out a form it’s a multi-step process that demands accuracy, correct formatting, and ongoing management.
Here’s how Registrar Corp simplifies it for you:
Determine Facility Scope and Obligations
We assess your business activities manufacturing, repacking, relabeling, or exporting and identify your exact FDA registration and listing requirements.
Submit to FDA via ESG Gateway
We transmit your registration and drug listings to FDA through the Electronic Submissions Gateway (ESG) and resolve any validation issues.
Appoint Registrar Corp as US Agent
You formally designate Registrar Corp as your US Agent, ensuring FDA has a reliable point of contact for inspections, safety alerts, and urgent inquiries.
Receive Submission Acknowledgment & Stay Compliant
Once accepted, we provide confirmation and continue to monitor your registration status managing annual renewals, listing updates, and FDA correspondence year-round.
What Could Go Wrong and Often Does
Assuming Approval Equals Market Readiness, overlooking the separate requirements for registration, product listing, and US Agent designation.
Using Generic or Placeholder SPL Templates that often leads to silent rejections leaving companies unknowingly non-compliant.
Treating the US Agent as a formality is risky; failure to respond to FDA notices or emergencies can result in import holds or inspection delays.
Annual registration renewals are frequently missed, which may lead to automatic deactivation without notification.
Why Global Drug Companies Choose Registrar Corp?
End-to-End FDA
Compliance From
registration to renewals,
we manage it all
Error-Free Submissions
SPL and NDC files
formatted to FDA standards
24/7 US Agent Support.
Immediate response to
FDA inspections and alerts
Proven Experience.
20+ years supporting
30,000+ FDA-regulated
businesses.
Global Reach, Local
Expertise. Trusted by
clients in over 160
countries.
Ready to enter the US market
with full confidence and zero guesswork?
Contact Us
"*" indicates required fields