Consulting

Build Stronger Systems. Close Critical Gaps.

AuraGxP helps life sciences organizations strengthen quality, learning, and vendor governance through practical, expert-led consulting.

Whether you are building from scratch, preparing for an inspection, or scaling an active program, we create processes that are clear, compliant, and scaled to your needs.

Talk to Our Experts

Our Consulting Capabilities

Two Pillars. One Stronger Operating Model.

Quality and Learning Management

Build quality systems that work in practice and stand up to regulatory scrutiny.

Quality System Gap Analysis
Identify compliance risks and prioritize remediation.
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SOP Development and Document Control Setup
Establish mission critical standard operating procedures for your stage of development and define the process for controlling documents at your organization.
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QMS Process Design
Establish or strengthen deviation, CAPA, change control, and risk management processes.
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Audit Program Design
Create risk-based internal, vendor, supplier, system, and process audit programs.
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Perform GxP Audits and Mock Inspections
Allow us to evaluate readiness, uncover vulnerabilities, and prepare teams for scrutiny.
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Quality Agreement or Transfer of Obligation Development
Define responsibilities across sponsors, CROs, CDMOs, laboratories, and suppliers.
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Training Program Design and Competency Framework
Schedule meetings, prepare performance data, facilitate reviews, document decisions, and track follow-up actions.

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Vendor Management and Governance

Bring structure, accountability, and control to every critical vendor relationship.

Vendor Selection and RFx Management
Let us help you set up RFIs, RFPs, evaluations, scoring, and selection criteria. Or have us run the whole process for you
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Design Vendor Oversight Frameworks
Define risk assessment criteria and scoring methodology, prioritize vendors based on risk, and design a plan for consistent oversight.
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Vendor Governance Strategy
Establish decision rights, meeting cadences, KPIs, scorecards, and escalation mechanisms.
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Vendor Strategy Analysis and Design Support
Review your vendor landscape to identify capability gaps, concentration risks, and sourcing opportunities.
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Contract and SOW Review
Review contracts to identify risk and liability gaps, help establish a standardized contract review checklist, and support negotiation as needed.

The Consulting Partner Your Program Deserves

Purpose-Built For Life Sciences Teams

Our consulting is delivered by specialists with hands-on experience inside life sciences organizations. We understand quality management, procurement, vendor oversight, clinical operations, and regulatory compliance at the operational level—not just as concepts.

Works With Your Existing Technology

AuraGxP consultants work within your existing QMS, ERP, eClinical, and procurement systems. We design and implement processes inside your current technology stack—whether that's Veeva Vault, SAP Ariba, MasterControl, OpenText, Workday, or SharePoint—without requiring platform changes or lengthy implementation projects.

Flexible Consulting For Every Program Stage

Choose the consulting support that fits where you are. Whether you need a gap assessment, a full quality system build, targeted remediation ahead of an inspection, or preparation for due diligence, we scope the engagement to your program.

Built To Hold Up Under Scrutiny

We build systems, processes, and governance structures designed to hold up under FDA, EMA, and MHRA regulatory scrutiny, board review, and due diligence. We deliver independent, objective assessments and practical implementations built to last—not merely compliant on paper at the time of transition.

Designed To Grow Into Managed Services

When consulting is complete, your systems are ready to operate. If you want us to take on ongoing operations, our managed services team picks up from there with no transition delay. If your team is running it in-house, we make sure they are properly set up before we step back.

Why AuraGxP

Works With Your Technology

Strengthen processes within your existing QMS, ERP, eClinical, procurement, and collaboration systems.
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Life Sciences Expertise

Work with specialists who understand quality, clinical operations, audits, procurement, and vendor governance.

Flexible Engagements

Start with a focused assessment, targeted remediation, system build, inspection-readiness program, or vendor-governance initiative.
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Built for Scrutiny

Create processes that can withstand regulatory inspections, sponsor audits, board reviews, and due diligence.
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Ready for Ongoing Operations

Transition the work to your internal team or continue with AuraGxP Managed Services.

Contact us to discuss how AuraGxP Consulting can be scoped for your program

Whether you're building from scratch, closing gaps ahead of an inspection, or preparing for due diligence

Talk to an AuraGxP Expert