Navigating FDA Compliance Together
Foreign drug and pharmaceutical establishments must designate a U.S. Agent before registering with the FDA. We serve as your official FDA representative managing all communications, coordinating inspections, and ensuring your drug establishment remains fully compliant year-round.
Drug Establishment Registration
Manufacturers, re-packers, re-labelers, and salvagers of human drugs must register their establishment with the FDA before doing business in the U.S. We manage your complete registration process.
- Initial Drug Establishment Registration
- Annual Renewal
- Drug Product Listing (NDC)
- Registration Amendments
Drug Product Listing (NDC)
Every drug product must be listed with the FDA and assigned a National Drug Code (NDC) before it can be marketed in the U.S. We handle the complete listing submission.
- NDC Number Assignment
- Drug Listing Submission (DRLS)
- Drug Listing Updates
- OTC Monograph Products
Structured Product Labeling (SPL)
FDA requires drug establishment registration, listing, and labeling data to be submitted electronically in Structured Product Labeling (SPL) format under 21 CFR Part 207. We prepare and submit compliant SPL files for every product.
- Prescription Drug SPL
- OTC Drug SPL
- SPL Updates & Amendments
- Establishment SPL
Drug Label Review
Manufacturers, re-packers, re-labelers, and salvagers of human drugs need labeling that meets FDA content and format requirements before it reaches the market. We review your labels for compliance before submission.
- OTC Drug Facts Panel Review
- Prescription Drug Labeling Review
- Homeopathic Drug Labeling
- Multi-Language & Import Labels
Animal & Veterinary Drugs
The FDA’s Center for Veterinary Medicine (CVM) regulates drugs intended for animal use. We manage registration, listing, and label compliance for veterinary drug establishments.
- Veterinary Drug Establishment Registration
- Veterinary Drug Product Listing
- Veterinary Drug Label Review
- Medicated Feed Registration
Drug Registration Renewals
Drug establishment registrations must be renewed every year between October 1 and December 31, or the registration deactivates automatically on January 1. We track your renewal window and file on time, every time.
- Annual Drug Establishment Renewal
- Drug Listing Updates
- U.S. Agent Annual Renewal
- Registration Amendments
Why Choose FDA Entry?
- Fast Turnaround: Most registrations completed within 24 to 48 hours. We understand time-to-market matters.
- Expert Team: Regulatory specialists with decades of combined FDA experience at your service.
- Transparent Pricing: Clear, upfront pricing with no hidden fees. Know exactly what you’re paying for.
- Secure & Confidential: Your proprietary information is protected with enterprise-grade security protocols.
READY TO ENSURE YOUR FDA COMPLIANCE?
Let’s discuss how we can support your drug or pharmaceutical business. Get a free consultation today.
Drugs & Pharma FAQs
Yes. A foreign drug or pharmaceutical establishment must designate a U.S. Agent before it can register with the FDA. The U.S. Agent serves as the official point of contact for FDA communications and inspection coordination.
Every year, between October 1 and December 31. Miss that window and the FDA automatically deactivates the registration on January 1 and removes the establishment’s products from the NDC directory.
Establishment registration covers the facility itself, where manufacturing, repackaging, or relabeling happens. Drug listing is separate and per-product: each drug gets its own National Drug Code (NDC) and listing record tied back to the registered establishment.
SPL is the XML-based format the FDA has required since 2009 for submitting drug establishment registration, listing, and labeling data. It’s not optional; registration and listing submissions that aren’t in SPL format won’t be accepted.