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GXP Quality Systems LogoGXP Quality Systems

UEI: CE75VFSBP963 • CAGE: 8NBB2
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Overview

Awardee Type
Parent
Federal Capability Statement
We are a contract research organization that offers quality systems-based solutions across the full spectrum of GXP. We engage with Clients to conduct a review of their quality system or audit of a specific activity. Following the review/audit, we compile findings, evaluate issues, document issues and actions, and formulate recommendations for review. Discussion of the findings/recommendations normally results in agreement of priority items to be addressed, a remediation plan, a timeline for execution and steps necessary for sustainability. Our wheelhouse includes product development and strategic Regulatory consulting services, from auditing to authoring procedures and technical documents (pertaining to preclinical, CMC and clinical operations), to consent decree and warning letter mitigation and PAI/PLI preparation, to regulatory submissions and electronic publishing services. We also provide medical/technical writing and review services for clinical operations, data mgmt/biostats.
Keywords
Gxp quality systems, good clinical practice, gcp, good laboratory practice, glp, good manufacturing practice, gmp, gxp, regulatory, medical writing, strategic consulting, gxp training, contract research organization, product development, regulatory approval, quality systems, quality, biotech, biopharma, electronic publishing, quality control, CMC, Pharmacovigilance, Preclinical research, clinical development
Headquarters
Southlake, TX
United States
Federal contract recipient GXP QUALITY SYSTEMS LLC (UEI CE75VFSBP963, CAGE 8NBB2) is headquartered in Southlake TX. Its primary registered NAICS is 541690 Other Scientific and Technical Consulting Services. The partnership was founded in August 2018 and federally registered in April 2020.

Federal Award Analysis

GXP Quality Systems federal award history

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Federal Registration and Certifications

Legal Name
GXP QUALITY SYSTEMS LLC
Division Number
GXP QUALIT
UEI
CE75VFSBP963
CAGE Code
8NBB2
SBA Certifications
None
Self Certifications
Self-Certified Small Disadvantaged Business
Entity Structure
Partnership or Limited Liability Partnership

People

Vendor contacts at GXP Quality Systems

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Subcontract Awards

GXP Quality Systems subcontract awards

Teaming Partners

Disclosed awardee sub and prime contract and grant relationships

GXP Quality Systems