FDA Registration
Your Gateway to U.S. Market Compliance.
Ensure seamless entry into regulated U.S. markets with expert guidance on FDA registration for food, medical devices, cosmetics, and pharmaceuticals.
Key Benefits of FDA Registration
Navigate U.S. regulations with confidence and unlock new market opportunities.
U.S. Market Access
Fulfill mandatory FDA requirements to legally sell your products in the United States.
Legal Compliance
Ensure alignment with the U.S. Code of Federal Regulations (21 CFR) for your specific industry.
Consumer Trust
Demonstrate adherence to stringent U.S. safety, quality, and labeling standards.
Risk Mitigation
Avoid costly penalties, import detentions, or shipment delays by ensuring proper registration.
Supported FDA Registrations
We provide expert guidance across a range of regulated industries.
Food Facilities
Registration under FSMA, FSVP Agent services, and PCQI assistance.
Medical Devices
Establishment registration, device listing, and 510(k) submission support.
Cosmetics
Assistance with voluntary registration (MoCRA), labeling, and ingredient review.
Pharmaceuticals
Establishment registration, drug listing, and cGMP compliance guidance.
Our FDA Registration Process
A structured approach to ensure a smooth and successful registration.
1. Application & Scope Definition
Submit your request and specify the product type. We help identify all relevant FDA regulations for your products.
2. Document Preparation & Review
We guide you in compiling all necessary FDA-required documents, such as Food Safety Plans, 510(k) data, or cGMP documentation.
3. Facility Inspection (If Required)
We provide coordination and preparation support for potential on-site FDA inspections of your facility.
4. Submission & U.S. Agent
We assist in submitting your application via the appropriate FDA system and facilitate U.S. Agent services if needed.
5. Confirmation & Renewal Support
You receive your FDA registration number. We provide ongoing support for annual renewals and compliance updates.
Why Choose CAS for FDA Registration?
Your expert partner for navigating U.S. market entry.
Regulatory Expertise
Our team is trained in relevant sections of 21 CFR and U.S. regulatory submission requirements.
End-to-End Support
We guide you through the entire process, from documentation and review to submission and renewal.
Global Reach, Local Presence
We assist clients in Egypt, Jordan, and the wider Middle East in successfully navigating U.S. market entry.
