Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF SEPTEMBER 04, 2022 SAM #7583
SPECIAL NOTICE

70 -- Simcyp Software Licenses Subscription

Notice Date

9/2/2022 11:24:06 AM
 

Notice Type

Justification
 

NAICS

511210 — Software Publishers
 

Contracting Office

FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
 

ZIP Code

20705
 

Solicitation Number

75F40122Q00139
 

Archive Date

10/02/2022
 

Point of Contact

Mark Brady, Phone: 240-402-4291
 

E-Mail Address

Mark.Brady@fda.hhs.gov
(Mark.Brady@fda.hhs.gov)
 

Award Number

75F40122P00441
 

Award Date

09/21/2022
 

Description

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:
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/9362d3f769444d9090b3233b7008d503/view)
 

Place of Performance

Address: Silver Spring, MD 20993, USA

Zip Code: 20993

Country: USA
 

Record

SN06451666-F 20220904/220902230123 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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