Domestic and Foreign Manufacturers of OTC Drugs

US Agent services for foreign drug manufacturer.

Foreign drug manufacturer is required to appoint U.S. Agent to communicate with the FDA.
We offer U.S. Agent services at lowest fee, please click here for more information.

Drug establishment registration

Manufacturer, Processor, Packer of the drug and drug testing laboratories are required to register with the FDA. Please contact us for more information.

Labeler code and drug listing for OTC and Prescription products

Manufacturer, Packer, processor and private label distributors are required to list the products. We can help you to obtain a labeler code and submit the drug listing. Contact us for more information.

FDA labeling compliance for OTC drugs

The drugs marketed in the USA must comply with FDA labeling requirements. Failure to comply with labeling requirements results in the detention, seizure and other FDA enforcement actions. We can help you to comply with labeling requirements, click here for more information.

Product Approval ANDA, NDA and IND

Most of the prescription drug requires prior approval from the FDA. We can assist you with product approval application through ANDA and NDA route. We also offer assistance for IND meeting. Click here for more information.

Other consulting services

We offer consulting services to answers your questions related FDA drug regulatory framework, and help you to comply with FDA requirements. Click here for more information.