Our Services
FDA Regulatory Services to Get Your Products Fully Compliant
FDA Food and Dietary Supplement Services
Food Facility Registration: FDA registration of facilities that manufacture, process, pack, or hold the food (including dietary supplements) for distribution in US commerce.
US Agent: Act as US Agent for foreign facilities (required for FDA registration of foreign facilities).
DUNS Application: To register as a food facility with FDA, the company must have a DUNS number. FSVP Importers must also have a DUNS number.
Label Review: Full report detailing all changes that must be made to bring the label into full compliance with U.S. federal regulations.
Food Canning Establishment (FCE) and Scheduled Process Identification (SID) Filing: Assisting manufacturers of low-acid canned food (LACF) or acidified food (AF) products with registration (obtaining FCE number) and process filing (obtaining SID).
Foreign Supplier Verification Program (FSVP): FDA now requires importation of most FDA-regulated foods to be approved under FSVPs which include analysis of food safety-related hazards and risk evaluation, supplier approval and performance evaluation, and documentation of any corrective actions.
Regulatory Report: Full report explaining the regulatory requirements for the product, identifying any potential problems for marketing it in the US, and advising how to resolve or prevent those problems.
APHIS VS Permit Application (VS 16-3): APHIS may require this permit for importing products that contain ingredients derived from animal material.
Regulatory Starter Blueprint (New!): For first-time food importers, this report summarizes the key requirements for importing foods into the United States and provides a checklist for you to complete. We then provide a verbal consultation over the phone or video conference (your preference) to go over the report and answer any questions you may have.
FDA Cosmetic Services
Cosmetic Listing: Submit listing of cosmetic product (intended for human use) to FDA which FDA now requires under the MoCRA for the manufacturer, packer, or distributor declared on the product label.
Label Review: Report detailing all changes that must be made to bring the label into compliance with U.S. federal regulations. Includes ingredient review.
APHIS VS Permit Application (VS 16-3): APHIS may require this permit for importing products that contain ingredients derived from animal material.
Regulatory Review: Report explaining the federal regulatory requirements for your product, identifying any potential problems for marketing it in the US, and advising how to resolve or prevent those problems.
FDA Medical Device Services
Medical Device Listing: Obtain FDA listing number which is required for medical devices intended for commercial human use.
Label Review: Report detailing all changes that must be made to bring the label into compliance with U.S. federal regulations.
510(k) Submission: Submit premarket notification, also known as “510(k)”, applications which are required for most class II medical devices and some class I medical devices.
Regulatory Review: Report explaining the federal regulatory requirements for your medical device product, identifying any potential problems for marketing the product in the US, and advising how to resolve or prevent those problems.
FDA Drug Services
Drug Facility Registration: FDA registration of drug establishments including manufacturers, re-packers, and re-labelers.
Drug Listing: Obtain drug listing number also known as the National Drug Code (NDC) which is required for drugs for commercial use.
Label Review: Report detailing all changes that must be made to bring the label into compliance with U.S. federal regulations.
Regulatory Review: Full report explaining the federal regulatory requirements such as requirements for ingredients, doses, and formulation. We identify any potential problems marketing the product in the US – and advise how to resolve or prevent those problems.
FDA Import Solutions
FDA Import Detention/Hold Resolution: Seeking FDA release of products from FDA hold or detention. We also assist companies with overturning refusals that resulted from FDA error or misjudgment.
Import Alert “Red List” Removal: Preparing and filing FDA petition to remove products from Import Alert Red Lists including assistance with corrective action plans and root-cause investigation reports to ensure the company and its products are removed from the Red List as quickly as possible.
Import Alert “Green List” Addition: Preparing and filing FDA petition to gain exemption from an Import Alert.