FDAbasics is a private consulting firm that offers U.S Agent services to foreign companies and is not affiliated with FDA. By accepting this agreement, FDAbasics and Company agree to follow the terms. Company means the receiving party of services
FDAbasics acts as U.S Agent for Company to facilitate communication between the FDA (U.S. Food and Drug Administration) and is only responsible for transmitting the information received from FDA to Company unless a specific service agreement exists.
U.S Agent agreement between Company and FDAbasics will remain effective for 12 months from the date of payment. Unless extended, this is the period specified.
U.S Agent fees do not include any other consulting or any regulatory work unless jointly agreed to by both parties.
Company warrants that the information provided in this form is Truthful and Accurate. It remains Companies responsibility to update any change in the provided information.
The Company acknowledges that FDAbasics is acting as U.S. Agent between the Company and the Food and Drug Administration and has no involvement or specific knowledge of the Company’s products.
Company will not hold FDAbasics liable for any negligence and/or damages whatsoever, including but not limited to any liability arising concerning the performance of the Company’s products.
Neither party to this contract shall be held responsible for a breach of contract caused by an act of God, insurrection, civil war, military or local emergency, or by any act or failure to act by the U.S. Food and Drug Administration.
In case of any breach of terms, FDAbasics has the right to terminate the services with seven days advance notice. In case of non-payment for renewal of services, FDAbasics may revoke all the provided services such as U.S Agent appointment, registration, listing or any other such services, and FDAbasics will not be responsible for any loss faced by the Company as a result of such action.
FDAbasics shall inform Company seven working days before taking any such actions.
This form is only for the specific services mentioned in the form. If you are looking for U.S. agent services for ANDA, IND, controlled correspondence, 510 K filings, please contact us.
U.S. agent and FSVP agent are two different requirements. This form is not for FSVP agent appointments. If you are looking for FSVP agent services, please contact contact us.
Without our written consent, you must not use FDABasics as an FSVP agent, for adverse event report purposes, or our company name on the product labels.
The U.S. agent contract is valid only for the facility’s name and address mentioned in the form. Each facility location requires a separate registration, and you have to pay the U.S. agent service separately. If you have multiple facilities, please contact us.
FDAbasics offers the most competitive pricing without compromising quality, and such statements regarding our pricing are not legally binding. However, we welcome our customers’ pricing feedback and shall try to meet your expectations.
Customers confidentiality is the top priority for FDAbasics, and FDAbasics will not intentionally disclose any confidential information to third parties unless mutually agreed to by FDAbasics and Company or required by the law