US Agent Services
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug substance or drug product imported into the United States must identify a United States agent (U.S. agent) for that establishment. Foreign companies are required to submit details about their Agent during Establishment Registration and GDUFA self-identification, and in all the regulatory submissions, including drug master file, ANDA and NDA.
Catain have expertise in the below areas.
Handling controlled correspondence
US Agent services for Pre-IND, IND, ANDA, NDA and DMF filing
IND filing and pre IND meeting request
Drug establishment registration, GDUFA Registration, Drug Listing, Labeler Code (NDC) request, and FEI number request.
Click here ==> US Agent Form
If you have questions, please get in touch.