Our scope of services is limited to Drug Listing, FEI number request, and GDUFA Self Identification (subjected to services mentioned in the invoice) request.

Product quality, safety efficacy, and product composition are responsibilities of product owners/manufacturers.

It remains your responsibility to comply with applicable requirements related to your product quality, safety, efficacy, manufacturing, control, and formulation.

There is no additional fee to add multiple pack sizes of the same product before submitting the drug listing to the FDA.

Any change in the active, inactive, product name, fragrance, dosage form, and route of administration will be considered a new product.

A separate fee is applicable for each product listing.

U.S. Agent fee applies to foreign facilities. A separate U.S. Agent fee will be charged for each establishment (company).

Labeling review and compliance are subjective. Our recommendations and advice are based on our knowledge and experience and do not constitute a guarantee of acceptance by the U.S. Food and Drug Administration. Catain does not offer legal advice and is not responsible for consequential damages resulting from any product rejection due to improper labeling or ingredients.

FDA does not review or approve OTC monograph drug labels.

The scope of the labeling review services does not include ingredient safety or product composition review. The scope of the labeling review is to verify content and format according to OTC drug labeling requirements.

To complete the drug listing, you must provide all the information requested in the form. Incomplete information may cause a delay in project completion.

Before submitting information to the FDA, we will send for review and approval. It remains your responsibility to make sure the information provided in the document is Truthful and Accurate.

The refund will not be issued once we start working on your project. The scope of services will be limited to those services mentioned in the invoice.

Catain is a private company and not associated with the United States Food and Drug Administration.

FDA does not issue the certificate for registration/ listing. You can verify the registration / listing status on the FDA website.

Catain shall issue the certificate of registration/ listing upon request from the customer. A certificate issued by our company does not form any form of endorsement for your product or company.

To process your submissions through the gateway, you must email an authorization letter to FDA for which we will provide the template.

Catain will send invoice after the submission has been submitted and accepted by FDA. All the invoices will be due in full within 7 days of invoice date.