An amendment was added to this solicitation. Objective The objective is to acquire required software, Certara Phoenix Licenses or equal, for a biopharmaceutics assessment. Requirements The contractor shall provide the Phoenix Quantum software licenses or equivalent that allows DBP to assess IVIVC modeling in quality assessments of drug applications. In order for a Quoter’s software and capability to be deemed acceptable, the following salient characteristics shall be met: Software Shall be able to take into account Drug-Drug Interaction (DDI) potential Support development of new and pediatric formulations Manage and produce virtual pharmacokinetic (PK) datasets Evaluate PK changes in specific and ‘special’ disease populations Investigate likely mechanisms behind clinically observed PK nonlinearities Mechanistically evaluate the likelihood and magnitude of quality specification impacts on in vivo response Software shall be able to input drug blood levels and provide deconvolutions Shall provide correlative outputs based on in vitro release data. Software shall provide complex statistical calculations based on Unit impulse responses of various data inputs to provide the statistical correlations and predictions of future datasets. Maintenance and Technical Support: At minimum the contractor shall: Deliver software updates Two business-day response to all software defect inquiries Availability of feature (level) upgrades Training : Access to on-site project training (e.g. vendor could provide a webinar for optimal software usage to multiple FDA staff) Instructions to Quoters Quoters shall submit a complete pricing for all products listed in this RFQ and overall cost to the Government. Partial quotes will not be considered. Incomplete pricing or pricing with omissions may not be considered for award. Quoters should 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. Quotations shall meet all the requirements of this solicitation in order to be considered technically acceptable. Quoters shall submit all assumptions in their quotation. Quoter shall be an Original Equipment Manufacturer, authorized reseller and/or servicing agent of the software manufacturer. Quotes shall meet all the salient characteristics of this solicitation. Quotes should contain all requirements outlined in Section 3 and 3.1 of this solicitation. Quoters shall submit all applicable terms and conditions in full text as attachments, appendix, or exhibits. Equal to Quotes must submit Technical volume with detailed point-by-point description of how the equal to product meets all the salient characteristics of this solicitation in Section 3.1 of this solicitation. Quoters submitting equal to products, shall 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-accessiblity-template/ Questions and quotes shall be submitted electronically via email to Sephora Calderon at
[email protected]. Evaluation: All quotes will be evaluated on a Lowest Priced Technically Acceptable (LPTA) basis. All quotes will be evaluated on proposed products that meet or exceed all the salient characteristics specified in Section 3.1 of this solicitation. The Government will evaluate the quotation that it meets the requirement in section 3 through Section 4 of the solicitation to include description, quantity, period of performance and pricing for the deliverables Section 508 Product Accessibility Basis of Award All quotations will be evaluated on a Lowest Priced Technically Acceptable (LPTA) basis. The award will be made to the lowest price Quoter that demonstrates they can meet all the requirements of this solicitation. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award.