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This Government Contract opportunity from Department Of Health And Human Services was posted on September 8, 2022. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Simcyp Software Licenses Subscription

Awarded
75F40122Q00139Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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General Info

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

NAICS

511210 - Software Publishers

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Documents

2

75F40122Q00139_SimCYP+Simulator+Software.docx

DOCX

Justification+and+Approval+Redacted.docx

DOCX

AI Contract Breakdown

Uniform Contract Format

Contract not broken down yet

CLEATUS splits the solicitation into Uniform Contract Format (UCF) sections: scope, pricing, deliverables, and evaluation criteria.

Timeline

2 updates
PhaseAwarded
Posted

Justification (J&A)

Justification (J&A)

Justification & Approval published

Justification (J&A)

Justification & Approval published

Awarded

Contract was awarded

Submission Closed

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Organization & Contact Information

Show more
AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
Contacts1 person available
OfficeBeltsville, MD, 20705, USA
Organization / AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
Office AddressBeltsville, MD, 20705, USA
Contacts
Mark Brady
contact@example.gov
+1 (555) 000-0000

Full Description

Show more
The U.S. Food and Drug Administration, Rockville, MD intends to award a firm -fixed price contract to renew FDA's subscription to Certara's Simcyp software licenses and associated maintenance. FDA intends to issue and award, to Certara UK Limited, Simcyp Division, Level 2-Acero, 1 Concourse Way Sheffield, UK S1 2BJ. FDA's Office of Clinical Pharmacology currently uses Simcyp to conduct Physiologically based pharmacokinetic (PBPK) modeling to review Investigational New Drug (IND), New Drug Applications (NDA) Biologics Licensing Applications (BLA), Abbreviated New Drug Applications (ANDA), and other submissions from sponsors. Reviewers and Pharmacometricians use the data to review sponsor submissions (pharmaceutical companies, academic institutions, and individuals) and adhere to schedules with timelines that must be met per the various user fee acts governing such work (Prescription Drug User Fee Act, Generic Drug User Fee Act, Biosimilars User Fee Act) and other FDA Missioncritical functions. If submissions are submitted to the FDA using Certara software they must also be reviewed using the Certara software, therefore no other PBPK modeling tool will meet OCP's needs. There are no set-aside restrictions for this procurement, and the anticipated Period of Performance is 9/21/2022 - 09/20/2023. Certara UK Limited offers a product with capabilities that are not available from any other vendor, and controls all propriety rights for this product:

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