FDA Agent Pro Scope of Services and Terms and Conditions Service: FDA Medical Device Label Review Scope of Services
Agreement for Label Review Service
We appreciate your decision to select FDA Agent Pro LLC (FDA Agent Pro) to review your product label for compliance with US FDA regulations. This Agreement describes the scope of our relationship with your company. By signing below and submitting this form to FDA Agent Pro LLC your Company agrees to be bound by the terms and conditions listed in this document
Scope of service -
Our services will be limited to review and update the label you provide to comply with current US FDA regulations to the best of our knowledge.We will provide you a report with recommendations and suggested label as per the service selected after completing the label review.We will provide you maximum of three additional reviews within sixty days for the same label. The fees for further reviews are fifty percent of original fees per review.The minimum time required for initial review report and suggested label is three weeks after we received the label and payment and three days for additional reviews.Duration of the Project is maximum sixty days after the initial review report.Client Information - All information’s and documents received from the client will be kept confidential.
Limitations - FDA Agent Pro LLC shall not be liable for any delay in performing its obligations under this agreement, if such delay is caused by circumstances beyond FDA Agent Pro’s reasonable control. FDA Agent Pro will not provide you any guarantee or assurance that the US FDA will accept the reviewed label as it is.
Notices - Either party may terminate the relationship at any time for any reason by providing seven days written notice to the other party. In the event FDA Agent Pro terminated this Agreement, FDA Agent Pro shall not be liable to your company for any reimbursement or damages. In no event shall the FDA Agent Pro's liability exceed the amount of the fees paid by your company to FDA Agent Pro in any given calendar year.
We appreciate your decision to select FDA Agent Pro LLC (FDA Agent Pro) to review your product label for compliance with US FDA regulations. This Agreement describes the scope of our relationship with your company. By signing below and submitting this form to FDA Agent Pro LLC your Company agrees to be bound by the terms and conditions listed in this document
Scope of service -
Our services will be limited to review and update the label you provide to comply with current US FDA regulations to the best of our knowledge.We will provide you a report with recommendations and suggested label as per the service selected after completing the label review.We will provide you maximum of three additional reviews within sixty days for the same label. The fees for further reviews are fifty percent of original fees per review.The minimum time required for initial review report and suggested label is three weeks after we received the label and payment and three days for additional reviews.Duration of the Project is maximum sixty days after the initial review report.Client Information - All information’s and documents received from the client will be kept confidential.
Limitations - FDA Agent Pro LLC shall not be liable for any delay in performing its obligations under this agreement, if such delay is caused by circumstances beyond FDA Agent Pro’s reasonable control. FDA Agent Pro will not provide you any guarantee or assurance that the US FDA will accept the reviewed label as it is.
Notices - Either party may terminate the relationship at any time for any reason by providing seven days written notice to the other party. In the event FDA Agent Pro terminated this Agreement, FDA Agent Pro shall not be liable to your company for any reimbursement or damages. In no event shall the FDA Agent Pro's liability exceed the amount of the fees paid by your company to FDA Agent Pro in any given calendar year.