Ensure Full Compliance with Expert FDA Registration Services
Our expert team streamlines the registration process, ensuring your products launch safely and meet all regulatory standards effectively.
About Our FDA Registration Services
As a trusted FDA registration firm, we specialize in guiding businesses through the complexities of market entry. Our team offers strategic insights and tailored solutions to ensure compliance with FDA regulations, paving the way for your product's successful market launch.
Our FDA Registration Services
Boost your product compliance with our expert regulatory oversight and strategic quality assurance approaches.
FDA Registration
Seamlessly navigate FDA registration complexities with our dedicated support. We manage all paperwork and submissions, ensuring full compliance with necessary regulatory standards for a successful launch.
Food Safety Plan
Build robust food safety protocols with our comprehensive services. We guide you in creating and implementing effective measures that meet FDA regulations, protecting your consumers and enhancing your brand reputation.
Label & Ingredient Review
Achieve full label compliance with our thorough review services. We meticulously analyze and recommend label adjustments to align with FDA guidelines, safeguarding you against regulatory pitfalls.
Mock FDA Inspection
Equip yourself for actual FDA inspections with our mock inspection service. By simulating realistic FDA inspections, we help you identify and rectify compliance issues proactively.
Commitment to Compliance Across All Industries
At Register FDA, we guarantee that your products, from food and beverages to biologics and OTC drugs, adhere to the highest regulatory standards.
Frequently Asked Questions
Answers To Commonly Asked Questions
"Does possessing a food facility registration authorize me to sell my products in the U.S.?"
Simply being registered does not imply FDA approval of your products, nor does it endorse them.
"Is it mandatory for foreign food facilities to appoint a U.S. Agent for registration purposes?"
Yes, foreign facilities must designate a U.S. Agent to facilitate communication with the FDA.
"What duties does a U.S. Agent for FDA food facility registration have?"
The U.S. Agent must reside in the United States and aid in both communication with the FDA and the coordination of inspections.
"Can I complete my food facility registration initially and appoint a U.S. Agent afterward?"
No, registration activation necessitates having a U.S. Agent from the outset.
"Is it possible to replace my U.S. Agent after the food facility registration?"
Yes, you are permitted to appoint a different U.S. Agent after registration.
"What options exist for a foreign company without a U.S. representative to act as a U.S. Agent?"
A third-party service, like FDA Specialist, can be employed to fulfill the role of U.S. Agent.
"What information is required for obtaining a U.S. FDA food facility registration?"
You need to provide specific details about your company and the types of food it manages. A DUNS number is also necessary for registration.
"If our manufacturer is registered with the FDA, does it mean their products are approved for sale in the U.S.?"
No, having a registration does not equate to FDA approval of the products.
"Can the U.S. Agent for my food facility registration be based outside the United States?"
No, the U.S. Agent needs to be based within the United States.
"Will the FDA accept a food facility registration from a non-U.S. government?"
No, to market foods in the U.S., facilities must be registered directly with the U.S. FDA.
