CERTARA SIMCYP Licenses Subscription (Brand Name or Equal)

*****Amendment 1 containing Q&A has been issued and please find it form the Attachments/Links******

1. Objective

The objective is to obtain annual CERTARA SIMCYP software licenses, brand name or equal, to allow Office of Clinical Pharmacology drug reviewers to complete the review of INDs, NDAs, BLAs, ANDAs, and other submissions from sponsors, which is the primary role of the Office.

2. Instructions to Quoters

This combined synopsis/solicitation is 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 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 shall meet all the requirements of this solicitation in order to be considered technically acceptable.

Quoters shall submit all assumptions in their quotation.

Quoters shall 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.

For Equal To software, Quoter must submit Technical volume with detailed point-by-point description of how the 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 software, Quoters 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/. If Quoters fail to address this Section 508 PAT in their quotes, they may be deemed non-responsive and not considered for award.

The Government will evaluate the quotation that it meets the requirement of the solicitation to include description, quantity, period of performance and pricing for the deliverables.

Please submit questions to Min Jie (Terry) Zeng via email at minjie.zeng@fda.hhs.gov by August 12, 2020, 5PM Eastern Time.

Please submit quotes to Min Jie (Terry) Zeng via email at minjie.zeng@fda.hhs.gov by August 19, 2020, 12PM Eastern Time.

3. Evaluation Criteria

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 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.