NONMEM License Renewal and Maintenance (Brand Name OR Equal)

The Office of Clinical Pharmacology receives Investigational New Drug (IND) and New Drug Applications (NDA). Within these submissions sponsors include clinical pharmacology and pharmacometric models created using NONMEM software. The models and results must be independently analyzed and verified by Office of Clinical Pharmacology drug reviewers using NONMEM software. This software will allow Office of Clinical Pharmacology drug reviewers to complete the review of Investigational New Drug (IND) and New Drug Applications (NDA), which is the primary role of the Office. This is a combined/synopsis solicitation issued under FAR Part 12 and 13.5 procedures. This is an unrestricted procurement. The NAICS code is 541519. Quoters shall certify their quotes to be valid for at least 30 days. Quoters shall submit a quote for all requirements listed in this RFQ. Partial quotes will not be considered. Incomplete pricing or pricing with omissions may not be considered for award. Quoters shall submit all assumptions in their quotation. Quoters are advised that additional terms and conditions submitted with their quotation that is in conflict of the terms and conditions of this solicitation may be deems as technically unacceptable and may not be considered for award. All additional terms and conditions must be submitted with its quotation. Quoters providing quotations must clearly state the overall cost to the Government. Quoters shall ensure that their initial submission represents their best pricing and that all information is provided to determine technical acceptability. The Government will not research items to determine compatibility; all information regarding compatibility must be contained within the quotation. Equal To quotes must meet all the salient characteristics in order to be considered technically acceptable. If the part numbers are different from the brand name part numbers, Quoters shall map their part numbers to the brand name part numbers. Equal to quotes must submit a separate Technical Quote with a detailed point-by-point description of how the Equal To products meet all the salient characteristics of this SOW. Quotes providing the brand name product are not required to submit separate Technical Quotes. Technical Quotes shall not contain pricing information. Equal To quotes shall include a breakdown of all costs associated with the integration of the proposed solution into FDA environment. These costs shall be incorporated in the overall cost to For equal to quotations, Quoters will submit Section 508 Product Accessibility Templates (PAT) in full text with their quotations. For more information regarding PATs see: http://www.hhs.gov/web/section-508/contracting/technology-products/product-accessiblitytemplate/ If Quoters fail to address this Section 508 PAT in their quotes, they may be deemed nonresponsive and not considered for award. The Government will award a contract resulting from this solicitation to the responsible quoter as a fixed‐price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the non‐cost factor (technical conformance to the requirements of the solicitation). The Quoter’s initial quotation shall contain the Quoter’s best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award.