Who needs FDA Drug Establishment Registration?

Companies involved in manufacturing, repacking, relabeling, or distributing drugs for the U.S. market may be required to register their establishment with the FDA, depending on their role and the product type. FDA Registration Assistance can help determine requirements and complete the registration process.

Is FDA drug establishment registration the same as FDA approval?

No. Establishment registration and drug listing are regulatory requirements for certain firms and products, but they are not the same as FDA product approval. Requirements vary by product category and intended use.

Do foreign drug companies need a U.S. Agent?

Many foreign firms working with FDA-regulated activities benefit from having a U.S. Agent for FDA communications. FDA Registration Assistance provides U.S. Agent support for companies worldwide.

What is drug listing and when is it required?

Drug listing is the process of submitting required product information to FDA for certain drugs marketed in the United States. Listing requirements depend on the product type and regulatory pathway. We can guide you through the applicable listing steps and documentation.

Can you help with drug labeling compliance?

Yes. We provide drug label compliance support to reduce misbranding risk, including review of required label elements, claims, and formatting based on the product category.

Do you support NDC and SPL submissions?

Yes. FDA Registration Assistance can help with NDC-related support and SPL submission workflows when required for your drug listing and labeling activities.