FDA Compliance
Expert guidance for international pharmaceutical manufacturers navigating FDA registration requirements under 21 CFR Part 207. From initial eligibility through ongoing compliance.
Discuss Your RegistrationUnderstanding the Requirement
The U.S. Food and Drug Administration requires all domestic and foreign establishments that manufacture, repack, relabel, or salvage drugs intended for the U.S. market to register with the FDA and list their products.
This requirement, governed by 21 CFR Part 207, is among the most demanding regulatory frameworks in the world. Non-compliance can result in import alerts, product detention, and loss of market access.
For international manufacturers, the process involves appointing a US Agent, completing the FDA Unified Registration and Listing System (FURLS) enrollment, and maintaining annual registration renewals — all while ensuring your manufacturing operations meet the FDA's stringent quality expectations.
Facility Registration
Register each manufacturing, repacking, or relabeling facility with the FDA via FURLS
Drug Listing
List all commercially marketed drugs, including active ingredients, dosage forms, and labeling
US Agent Designation
Foreign establishments must designate a US-based agent to serve as FDA's point of contact
Annual Renewal
Registrations must be renewed annually between October 1 and December 31
Applicability
Any foreign establishment involved in the manufacture of drug products for the US market must register with the FDA.
Finished dosage form manufacturers producing for US distribution
Active pharmaceutical ingredient manufacturers and suppliers
CMOs producing pharmaceutical products on behalf of US-market clients
Companies that repack or relabel drugs for US market distribution
Our Methodology
A structured, proven approach to achieving and maintaining FDA registration for international manufacturers.
We evaluate your manufacturing operations, product portfolio, and target market to determine registration requirements and identify any compliance gaps.
We assist with designating a qualified US Agent who will serve as your point of contact with the FDA, ensuring responsive communication with the agency.
We guide you through obtaining a DUNS number, creating an FDA industry account, and preparing all required documentation for the registration submission.
We complete and submit your facility registration through the FDA's FURLS system, including payment of the annual establishment registration fee.
We prepare and submit your drug product listings, including NDC numbers, active ingredients, dosage forms, routes of administration, and labeling information.
We manage your annual renewal, listing updates, and any required amendments — ensuring continuous compliance and readiness for FDA inspections.
Regional Focus
We specialize in helping pharmaceutical manufacturers in Syria, Saudi Arabia, and Egypt navigate the complexities of FDA registration. Our team understands the local regulatory landscape and maintains direct relationships with regional authorities to facilitate the qualification process.
Whether you are a contract manufacturer seeking to expand into the US market, an API producer looking to register your facility, or an established pharmaceutical company pursuing FDA compliance for the first time — our bilingual team provides end-to-end guidance in both English and Arabic.
Take the First Step
Contact our regulatory team for a confidential assessment of your registration requirements. We'll outline the pathway, timeline, and investment needed to achieve FDA compliance.
Or email us at info@[domain].com