Simulations Plus, Inc.s GastroPlus Software Licenses

Notice-of-Intent (NOI) PANMRA-21-P-0000 005645 The U.S. Army Medical Research and Development Command (USAMRDC) and the U.S. Army Medical Research Acquisition Activity (USAMRAA), in support of the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD), intends to issue sole source, firm-fixed priced (FFP) solicitation W81XWH-21-Q-0175 for Simulations Plus, Inc.s GastroPlus software license renewal. The authority for the sole source justification and other than full and open competition procedures will be in accordance with (IAW) FAR 13.106-1(b)(1)(i), Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements. The requirement entails renewing existing Simulations Plus, Inc.s GastroPlus software licenses, as well as adding new GastroPlus AIDD Module to both existing licenses for the USAMRICD. Simulation Plus, Inc.s GastroPlus software, is a mechanistically based simulation software package that simulates intravenous, oral, oral cavity, ocular, inhalation, dermal/subcutaneous, and intramuscular absorption, pharmacokinetics, and pharmacodynamics in animals. Simulation Plus, Inc.s GastoPlus software is a premier developer of drug discovery/development software and provide preclinical and clinical pharmacometric (mathematical) for regulatory submissions for quantitative systems with pharmacology models for drug induced liver injury, kidney injury, and nonalcoholic fatty liver disease. The software is used to conduct drug research by major pharmaceutical and biotechnology companies. The anticipated period-of-performance (POP) of this contract is one (1) year. Simulations Plus, Inc. is the sole manufacturer, provider and seller of the GastroPlus software. The North American Industry Classification System (NAICS) for this requirement is 511210 Software Publishers and the size standard of $41,500.000.00. PSC 7A20 IT and Telecom'Application Development Software (Perpetual License Software). This announcement fulfills the synopsis requirements under FAR 5.203(a). Interested concerns must identify their capability in writing (formats for submission: PDF, MS Word, or MS Excel) to Ms. Maribel C. Fratina, Contract Specialist, at email: maribel.c.fratina.civ@mail.mil and Mr. Ayi J. Ayayi, at email: ayi.j.ayayi.civ@mail.mil, no later than (NLT) fifteen (15) days after the publication of this notice 26 July 2021 at 1000 Eastern Standard Time (EST). This NOI announcement for Simulations Plus, Inc., for GastroPlus software licenses renewal, is not a request for competitive quotations. However, the Government will consider all responses received. After the publication of this NOI PANMRA-21-P-0000 005645, solicitation W81XWH-21-Q-0175 will be posted on or about 10 August 2021. The Government will not be responsible for any cost incurred in preparation of quotations. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a subsequent competitive procurement. All interested parties may submit a response for consideration via email to Ms. Maribel C. Fratina, Contract Specialist, at email: maribel.c.fratina.civ@mail.mil and Mr. Ayi J. Ayayi, at email: ayi.j.ayayi.civ@mail.mil.