FDAbasics is a private consulting firm and offers U.S Agent services to many companies. FDAbasics is not affiliated with FDA. By accepting this agreement, you agree to the terms and conditions listed below. Company means the receiving party of services.
FDAbasics shall act as U.S Agent for Company to facilitate the communication between FDA (US 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 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.
The company will not hold FDAbasics, its employees, directors, or associates liable for any negligence and/or damages whatsoever, including but not limited to any liability arising with respect to the performance of the Company’s products.
Neither party to this contract shall be held responsible for 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 Pragmatic 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.
Customers’ confidentiality is the topmost priority for FDAbasics and we will not intentionally disclose any confidential information to third parties unless mutually agreed to by FDAbasics and Company or required by the law.
Payments made against US agent services are non-refundable.
We shall send the US Agent details to the address mentioned in the US Agent appointment form.