Our Services
FDA Regulatory Services to Ensure Compliance
FDA Food and Dietary Supplement Requirements
Ensure that foods and dietary supplements are safe, properly labeled, and manufactured under sanitary conditions to protect the public health before they enter the U.S. market.
Read MoreFDA Cosmetics Requirements
Ensure cosmetic products are safe for consumer use, properly labeled, and manufactured responsibly to protect public health.
Read MoreFDA Medical Device and Drug Requirements
Ensure medical devices and drugs have met all FDA premarket requirements, are properly labeled, and are manufactured under conditions meeting federal standards.
Read More24 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
Manufacturers
Importers
Exporters
Distributors
Private Label Brands
Startups & Enterprises
Why Choose Us
Why Leading Organizations Choose FDA Specialist
Highly Experienced Team
Led by Richard Chiang who was an FDA official for 13 years and has 11 years of additional experience in the FDA-regulated industry. Get insider knowledge from those who’ve worked within the agency and who have practical industry experience.
Comprehensive FDA Expertise
Full-service compliance support for Foods, Dietary Supplements, Cosmetics, Medical Devices, and Drugs—all your FDA needs covered.
Import Problem Resolution
Specialized experience resolving FDA import Detentions, Refusals, and Import Alerts to get your products through FDA and Customs efficiently.
Premarket Solutions
Expert guidance in avoiding pitfalls that can lead to FDA enforcement actions and extensive regulatory delays.
Transparent Pricing
No hidden fees, upselling, or other disingenuous sales tactics. We focus on ensuring that you comply with FDA regulations rather than wasting time trying to sell you any services that you do not need.
Proven Track Record
Expert staff with decades of combined regulatory experience helping companies successfully navigate FDA requirements from registration through ongoing compliance.
How We Help
How FDA Specialist Can Help Companies Like Yours
Register Facilities & List Products
Serve as Your US Agent for Foreign Facilities
Fix Non-Compliant Labels Before They Cause Problems
Get Your Products Released from FDA Hold or Detention
Remove Your Company from FDA Import Alert Red Lists
Meet All Premarket Requirements to Avoid Unexpected Regulatory Delays
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?"
“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
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...