The American market is an appealing commercial prospect for a wide array of foreign industries. For establishments needing to register with the FDA, designating a US agent is an absolute requirement. While US Agents have a limited role in premarket submissions, it is prudent for foreign manufacturers to have one that is well-versed in regulatory pathways to ensure fair treatment.
The responsibilities of a US Agent include:
Serving as the principal liaison between the FDA and the foreign company.
Answering questions pertaining to the products that the foreign manufacturer intends to export to the US.
Assisting the FDA in determining inspection dates of the foreign establishment’s international facilities.
Communicating with the FDA if the foreign company’s representatives are physically absent or difficult to contact.
At VZG, our US Agent services consist of the following:
VZG shall keep a physical presence in the US on your behalf
We will provide updated information about your business that the FDA requires, such as establishment registration, product categories, telephone numbers, fax numbers, and email addresses.
We shall serve as your conduit to the FDA and keep you apprised of the inspection dates of your foreign facilities. Additionally, we will help you determine which units need to register with the FDA.
We shall keep you abreast of any FDA rule changes that can potentially impact your business.
Why Choose VZG?
Take advantage of VZG professionals’ supreme proficiency in the FDA regulatory process and reliability as US liaisons.
Client Satisfaction is Guaranteed
Trust VZG to be your partner and advocate as long as you are doing business in the US.
On top of our extensive experience in the industry, you get every penny’s worth through our comprehensive package and value-added services.