Our Services
FDA Regulatory Services to Get Your Product Approved
FDA Food Requirements
Ensure that food products are safe, properly labeled, and manufactured under sanitary conditions to protect public health before and after entering the U.S. market.
Read MoreFDA Medical Devices Requirements
Ensure medical devices are safe, effective, and compliant through proper classification, regulatory approval, quality standards, and ongoing monitoring before and after U.S. market entry.
Read MoreFDA Cosmetics Requirements
Ensure cosmetic products are safe for consumer use, properly labeled, and manufactured responsibly to protect public health.
Read More13 Years of FDA Experience
Former FDA Officials on Your Side
At FDA Specialist, we have experts in all the major spaces of FDA regulation covering foods, medical devices, pharmaceuticals, cosmetics, and other areas. Our experts are former investigators, reviewers, compliance officers, and headquarters officials. We also have technical experts from the regulated industries. Having this broad array of experts, each focusing on specific areas of FDA regulation, allows us to provide the most effective solutions for the needs of our clients.
Worldwide FDA Consulting
Industries We Support
We provide regulatory support and compliance solutions for FDA-regulated industries, including pharmaceuticals, medical devices, and biologics—helping companies meet requirements, maintain quality, and achieve successful product approvals.
Manufacturers
Importers
Exporters
Distributors
Private Label Brands
Startups & EnterprisesWhy Choose Us
Why Leading Organizations Choose FDA Specialist
Former FDA Officials
Led by Richard Chiang with 13 years FDA experience as field investigator. Get insider knowledge from those who’ve worked within the agency.
Comprehensive FDA Expertise
Full-service compliance support for Food, Medical Devices, Cosmetics, and Drugs—all your FDA needs covered.
Import Problem Resolution
Specialized experience resolving FDA Import Alerts and Detentions to get your products through customs efficiently.
Foreign Supplier Verification
Expert FSVP guidance ensuring your foreign suppliers meet FDA requirements and protecting your supply chain.
Free Expert Consultation
Every client receives a complimentary 30-minute consultation to assess needs and develop your compliance strategy.
Proven Track Record
Decades of regulatory experience helping companies successfully navigate FDA requirements from registration through ongoing compliance.
How We Help
How FDA Specialist Can Help Companies Like Yours
Get Your Products Released from FDA Detention
(Import holds resolved quickly with corrective action plans)
Remove Your Company from FDA Import Alert Red Lists
(End automatic detention with proven petition strategies)
Fast-Track 510(k) Clearance for Medical Devices
(First-time approvals with complete regulatory submissions)
Register Facilities & Obtain Required Listings
(Food, device, and drug establishments properly registered)
Fix Non-Compliant Labels Before They Cause Problems
(Comprehensive reviews for food, devices, drugs, cosmetics)
Serve as Your US Agent for Foreign Facilities
(Required representation for international companies)
Most Common Question
Frequently Answered Question
This section answers common questions about FDA registration, product approval, licensing requirements, and compliance processes. It is designed to help businesses and individuals understand FDA regulations, application steps, and important guidelines in a simple and straightforward way.
"If I have a food facility registration, does that mean I can go ahead and sell my food in the US?"
facility registration is only one of FDA’s regulatory requirements for marketing foods in the United States. Having a food facility registration does not mean that FDA endorses or approves your foods. When your company is registered, it enters FDA’s Official Establishment Inventory which allows FDA to locate your firm and determine whether it wishes to inspect your facility.
“Do I need to have a US Agent for FDA food facility registration?”
Foreign registrants must have a US Agent for US FDA food facility registration.
“What are the responsibilities of the FDA food facility registration US agent?”
The FDA food facility registration’s US agent must be located in the US and be able to receive communications from FDA and assist FDA with scheduling inspections of the foreign facility if needed.
Our Updates
Latest News
Stay updated with the most recent FDA announcements, regulatory changes, compliance alerts, and industry news to help you make informed decisions and keep your products aligned with current standards.
How to Make Sure Your Products Pass FDA‘s Label Exam!
It is critical that you make sure your products comply with FDA’s labeling regulations because the labels are usually the first things that an FDA inspector sees when they examine your products! At a quick glance, your labels may appear to be just fine because they...
Cosmetics – Who Must Register and List?
If you market cosmetic products, you probably have heard that with the passage of the Modernization of Cosmetics Regulation Act, or “MoCRA”, the FDA is now enforcing mandatory registration and listing requirements for the cosmetics industry. So who exactly must...
What Happens if You Fail an FSVP Inspection: FDA 483s, Warning Letters, and Import Alert
What Happens if You Fail an FSVP Inspection: FDA 483s, Warning Letters, and Import Alert The FEI is a unique identifier that FDA uses to identify firms associated with FDA regulated products. FDA is now placing importers on the Red List of Import Alert 99-41...