Welcome to FDADesignatedAgent.com.
The U.S. FDA has approved regulation that ALL Foreign Establishments
whose products (Human Drugs, Animal Drugs, Biological Products, Devices
and Foreign Food Establishments) are imported or offered for import into
the United States MUST register with the FDA and MUST identify a United
States Agent.
FDADesignatedAgent.com is a division of mdi Consultants, Inc. mdi
Consultants has created FDADesignatedAgent.com in order to provide you
the complete service on how to register with the FDA as well as act as
your representative in the United States.
- Why choose FDADesignatedAgent.com to be your U.S. representative?
- We have been working in the FDA regulated industries for over 20
years.
- We represent 100’s of companies as their U.S. designated agent.
- mdi Consultants also offers many other FDA-related services to
assist you in marketing and selling your product in the U.S., like
510(K) submission, cGMP compliance, ISO compliance, etc.
What are the next steps?
- Visit either the Foreign Food Establishment or
Pharmaceutical/Device section of our website to learn more about the
FDA regulation.
- Once you choose mdi Consultants, Inc. to be your Designated Agent,
you will need to fill out specific forms and then send those forms to
us.
You will find our rates within each of the relevant sections of our
website. If you have more questions about Designated Agents, please
contact us through our Inquiry Form.
You can also visit the website of mdi Consultants, Inc. to learn
about the other U.S. and European regulatory and compliance consulting
services that we offer.
Click here
to visit the web site of mdi Consultants, Inc.
