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FDA Registration/U.S Agent

Product Introduction
- To register at FDA, companies outside of the U.S must designate an U.S agent for FDA communications.
- Jasdi and our partner, Compliance Engineering can serve as your agent to help customers with the FDA registration for Over-The-Counter (OTC) products in order to export to the U.S market.

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Our Services:

1.FOOD AND BEVERAGES* :

We provide FFR, FCE registration and U.S. Agent for Non-U.S. Companies.

FFR : Food Facility Registration

FCE : Food Canning Establishment

SID : Submission Identifier

2.Over-the-Counter*:

We provide OTC registration and U.S. Agent for Non-U.S. Companies.

OTC : Over-the-Counter

NDC : National Drug Code

FDA 2023 Facility User Fee Rates:
a. Monograph Drug Facility (MDF) Facility Fee: USD 26,153
b. Contract Manufacturing Organization (CMO) Facility Fee: USD 17,435

3.Medical Devices * :

We provide the registration and U.S. Agent for Non-U.S. Companies.

Medical Devices user fee for 2023 : USD 6,493

4. Cosmetic :

FDA has stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP) effective March 27, 2023 as a result of FDA’s plans to develop a program for submission of the facility registrations and product listings mandated by the “Modernization of Cosmetics Regulation Act of 2022” (MoCRA).

Products

FDA Registration/U.S Agent

Product Introduction

Our Services:

1.FOOD AND BEVERAGES* :

2.Over-the-Counter*:

3.Medical Devices * :

4. Cosmetic :

*DUNS required.

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