FDA Agent Pro Scope of Services and Terms and Conditions Service: OTC Drug Listing Scope of Services
Agreement for Drug Listing with US Food and Drug Administration
We appreciate your decision to select FDA Agent Pro LLC to list your drug or drugs with United States Food and Drug Administration. 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
1. Services Provided. Our services will be limited to prepare the SPL file from the data you provided in this form and submit it to the United States Food and Drug Administration via Electronic Submission Gateway (ESG). FDA Agent Pro LLC will not verify the data or the product labeling submitted by you. FDA Agent Pro LLC provides Electronic Submission assistance only.
2. Client Information. You agree and warrant that all information that your company provides to FDA Agent Pro LLC including but not limited to any information necessary to list your drug with the US FDA is true and accurate. You understand and agree that the information you provided will not be privileged or confidential. You also understand and agree that the SPL may be prepared by FDA Agent Pro LLC or its associates.
3. Authorization. You authorize FDA Agent Pro LLC to prepare and submit the SPL file to United States Food and Drug Administration on behalf of your Company.
4. 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 LLC's reasonable control. FDA Agent Pro LLC will not provide you any guarantee or assurance that the US FDA will accept the data or Label submitted by you. You acknowledge and understand that FDA Agent Pro LLC will not verify the data or the product labeling submitted by you.
1. Services Provided. Our services will be limited to prepare the SPL file from the data you provided in this form and submit it to the United States Food and Drug Administration via Electronic Submission Gateway (ESG). FDA Agent Pro LLC will not verify the data or the product labeling submitted by you. FDA Agent Pro LLC provides Electronic Submission assistance only.
2. Client Information. You agree and warrant that all information that your company provides to FDA Agent Pro LLC including but not limited to any information necessary to list your drug with the US FDA is true and accurate. You understand and agree that the information you provided will not be privileged or confidential. You also understand and agree that the SPL may be prepared by FDA Agent Pro LLC or its associates.
3. Authorization. You authorize FDA Agent Pro LLC to prepare and submit the SPL file to United States Food and Drug Administration on behalf of your Company.
4. 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 LLC's reasonable control. FDA Agent Pro LLC will not provide you any guarantee or assurance that the US FDA will accept the data or Label submitted by you. You acknowledge and understand that FDA Agent Pro LLC will not verify the data or the product labeling submitted by you.