Precision Auditing.
Pharmaceutical Compliance
You Can Trust.
GxP Global Quality Network delivers expert GxP pharmaceutical auditing, regulatory compliance consulting, and quality assurance services to pharmaceutical, biotech, and life science organizations nationwide.
30+
Years of Experience
6
GxP Specialty Areas
100%
Compliance Focused
FDA
Regulatory Expertise
Monica Brooks, MSc
Principal & Senior GxP Auditor
GCP / GLP Auditing
FDA Regulatory Affairs
Quality System Development
Inspection Readiness
GxP Compliance Training
GxP Global Quality Network • Independent Consulting Partners
30+
Years Experience
GXP Network
Approved
About GxP Global Quality Network
Expert GxP Consulting Led by Monica Brooks, MSc
GxP Global Quality Network was founded to bring senior-level pharmaceutical auditing and compliance expertise directly to organizations that need it most. Led by Monica Brooks, a credentialed Principal & Senior GxP Auditor, we provide the strategic insight and hands-on execution your quality programs demand.
- Comprehensive auditing across all GxP disciplines, GCP, GLP, GDP
- FDA regulatory affairs expertise with hands-on submission support
- Quality management system development, remediation, and optimization
- Inspection readiness programs and mock FDA inspection preparation
- GxP compliance training programs tailored to your organization
Our Services
Comprehensive GxP Auditing & Compliance Services
Request a ConsultationGCP Auditing
Good Clinical Practice audits to ensure clinical trial integrity, patient safety, and data reliability in accordance with FDA, ICH E6, and global regulatory standards.
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Regulatory Affairs
Strategic regulatory consulting for FDA submissions, NDA/BLA/ANDA filings, IND applications, and ongoing regulatory compliance management throughout the product lifecycle.
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Quality Systems
Quality Management System development, implementation, remediation, and optimization. Building robust QMS frameworks, SOPs, CAPA systems, change control, and deviation management.
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Inspection Readiness
Proactive FDA and regulatory inspection preparation including mock inspections, gap assessments, front room/back room readiness, and corrective action planning.
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GxP Training
Customized GxP compliance training programs for pharmaceutical and biotech staff. Covering GCP, GLP, data integrity, and regulatory requirements at all organizational levels.
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Why GxP Global Quality Network
The Right Expertise.
At the Right Time.
When compliance is non-negotiable and regulatory stakes are high, you need a partner who brings both strategic depth and operational precision to every engagement.
01
Senior-Level Expertise
Monica Brooks brings 30+ years of pharmaceutical auditing and regulatory experience, you get direct access to senior expertise, not junior staff.
02
Senior Independent Practice
As a a senior independent consulting network, GxP Global Quality Network upholds rigorous professional and regulatory currency standards.
03
Tailored to Your Needs
Every engagement is customized. Whether a focused audit or comprehensive compliance program, our approach is structured around your specific regulatory environment and goals.
04
Pharma & Biotech Focused
We work exclusively in life sciences, giving you deep, current industry knowledge across pharmaceutical, biotech, and medical device sectors.
Areas of Expertise
GCP / GLP / GDP
Full GxP spectrum audit capabilities
FDA Regulatory Affairs
Submissions, IND, NDA, BLA, ANDA
Quality Management Systems
QMS build, remediation & optimization
Inspection Readiness
Mock FDA inspections & gap analysis
Data Integrity & Compliance
21 CFR Part 11, ALCOA+ principles
Ready to strengthen your compliance posture?
Monica Brooks, MSc
Principal & Senior GxP Auditor • (302) 760-9814
Get Started Today
How We Work
A Clear, Structured Engagement Process
01
Initial Consultation
We begin with a discovery conversation to understand your compliance needs, regulatory environment, timelines, and specific objectives.
02
Scope & Proposal
We develop a tailored engagement proposal with defined scope, deliverables, methodology, and timeline specific to your situation.
03
Audit & Analysis
Our expert conducts the audit or consulting engagement with rigorous methodology, documentation, and regulatory knowledge.
04
Findings & Recommendations
You receive a comprehensive findings report with prioritized observations, risk ratings, and actionable corrective recommendations.
05
Ongoing Support
We provide follow-up support for CAPA implementation, re-audits, and ongoing compliance program development as needed.
★ Now Accepting New Members
Are You a GxP Auditor or
Quality Professional?
Join the GxP Global Quality Network to collaborate on engagements, exchange job referrals, and connect with a trusted community of pharmaceutical and clinical research professionals.
GCP Auditors
GMP Auditors
Regulatory Affairs
Quality Systems
GVP / Pharmacovigilance