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This Combined Synopsis/Solicitation opportunity was posted on June 25, 2019. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Phoenix Quantum Licenses and Support or Equal

Closed
FDA-SOL-19-1213138Federal

Contract Overview

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

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General Info

Agency

N/A

NAICS

511210 - Software Publishers

Place of Performance

11785 Beltsville Drive., Rm 5409B, calverton, MD, 20705, USA

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Timeline

PhaseClosed
Posted

Combined Synopsis

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyN/A
Contacts2 people available
OfficeN/A
Organization / Agency
N/A
Office AddressN/A
Contacts
Mark L. BradyContract Specialist

Full Description

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The Office of Science receives tobacco product applications through multiple regulatory pathways including Substantial Equivalence (SE), Modified Risk Tobacco Product Applications (MRTPA), and Premarket Tobacco Applications (PMTA). Within these submissions sponsors include pharmacology and pharmacometric data (PK/PD modeling, non-linear mixed effects modeling, and other such data). These data must be independently analyzed and verified by Office of Science reviewers. Phoenix Quantum includes Phoenix WinNonlin, NLME, IVIVC, Connect, and Trial Simulator which provide the necessary tools to perform these data analyses. CTP is seeking to purchase 29 licenses for Phoenix Quantum or equivalent to allow Office of Science reviewers to complete the review of SEs, MRTPAs, PMTAs, and other submissions from sponsors, which is the primary role of the Office. This is a combined synopsis/solicitation for commercial software and services prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

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Miguel
Hillary
Keith Deutsch
Christine

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