Background The Division of Product Quality Research (DPQR) supports the modernization of pharmaceutical manufacturing by conducting regulatory science research on emerging technologies. Industry trends are increasing the regulatory challenges in quality, manufacturing and drug product development. The complexity of manufacturing processes and controls is increasing, as is the complexity of products (i.e., drug substance, formulation and/or container and closure system). Clinical designs and development timelines are evolving and accelerating, respectively, which must be supported by more agile and flexible manufacturing technology platforms. The development of process models and simulations can be used to identify product quality risks for emerging manufacturing technologies. Discrete Element Modeling (DEM) enables the detailed analysis and visualization of the flow of particles from powders to tablets. DEM simulation software has many applications within the pharmaceutical industry including predicting pharmaceutical powder flow properties, study effects of critical process parameters for blending, coating, milling, granulation, and compaction, identify edge of process failure, evaluate control strategies, and provide key information on process otherwise difficult or impossible to measure. Currently, DPQR possesses a license for a DEM modeling and simulation software package that provides a high-level modeling for particles (including API, excipients, coating etc.). The modeling and simulation software has the capabilities to support a wide range of emerging manufacturing technology projects including continuous drug product unit operations. To maintain this capability, DPQR is requesting the acquisition or renewal of one (1) license for the process modeling and simulation software platform to support drug manufacturing process evaluation. Objective The objective is to renew a license for EDEM or equal. EDEM is a DEM modeling and simulation platform including EDEM Creator for setting up a simulation model, EDEM simulator for fast and efficient simulation, EDEM Analyst for post-processing review and analysis, EDEM Application Programming Interface for utilizing custom models, and EDEM coupling interface to couple with other computer aided engineering model platforms. Instructions to Quoters This solicitation is issued under FAR Part 12 and 13.5 procedures. This is an unrestricted procurement. The NAICS code is 541519. The small business size standard is $30 million. Quoters shall certify their quotes to be valid for 30 days. Quoters shall be Original Equipment Manufacturers, authorized resellers and/or servicing agents of the software manufacturer. Quoters should ensure that all information is provided to determine technical acceptability and that their initial submission represents their best pricing. The Government will not research items to determine compatibility; all information regarding compatibility must be contained within the quotation. Quotations must meet all the requirements of this solicitation in order to be considered technically acceptable. Quoters shall submit all assumptions in their quotation. All Quoters providing quotations must clearly state the overall cost to the Government. Quoters shall submit a complete pricing for all products listed in this RFQ. Partial quotes will not be considered. Incomplete pricing or pricing with omissions may not be considered for award. Equal To quotations must submit Technical volume with detailed point-by-point description of how the equal to product meets all the salient characteristics of this solicitation. Equal to Quotations shall be required to operate seamlessly with connecting operating software and/or hardware. Equal To solutions 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 the Government. 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-accessiblity-template/. Please submit questions to Min Jie Zeng via email at
[email protected] by May14, 2020, 12PM Eastern Time. Please submit quotes to Min Jie Zeng via email at
[email protected] by May 22, 2020, 12PM Eastern Time. Evaluation Criteria The Government shall 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 should 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.