Consulting
AuraGxP can help you build the operational foundation your organization needs—by providing experts to augment your internal knowledge.
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We provide practical consulting across quality, procurement, vendor oversight, and spend management to help life sciences organizations build the systems they need to grow, scale, and stay compliant.
AuraGxP Consulting closes gaps, builds processes, and creates the infrastructure your program needs to hold up under regulatory scrutiny, board review, and the pressure of an active clinical program.
AuraGxP Consulting closes gaps, builds processes, and creates the infrastructure your program needs to hold up under regulatory scrutiny, board review, and the pressure of an active clinical program.
Our Capabilities
The Four Pillars Of AuraGxP Consulting
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Quality
Build a quality management system, controlled document framework, CAPA process, and training infrastructure into a single compliant quality foundation.
No undocumented processes, no inspection surprises, no quality gaps left to find.
No undocumented processes, no inspection surprises, no quality gaps left to find.
- Assess Your Quality Posture through independent gap assessments that identify regulatory compliance gaps, priority findings, and a clear remediation path.
- Design and Implement Your QMS with document hierarchy, version control, controlled templates, and review cycle workflows built for long-term use.
- Build CAPA and Training Infrastructure through deviation management systems, GxP training curricula, LMS setup, and competency tracking designed to hold up under inspection.
- Establish Change Control and Inspection Readiness with change management processes, ALCOA+ data integrity practices, and audit-ready documentation for FDA and EMA regulated environments.
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Procurement
Design procurement processes, supplier qualification programs, contract frameworks, and purchasing controls into a single governed procurement model.
No undocumented vendor decisions, no unqualified suppliers, no procurement compliance gaps.
No undocumented vendor decisions, no unqualified suppliers, no procurement compliance gaps.
- Build a Structured Procurement Process with the policies, SOPs, and workflows your organization needs to select, qualify, and manage suppliers the same way every time.
- Develop Your Approved Supplier List with qualification criteria, documentation standards, and maintenance processes tailored to your program requirements and regulatory environment.
- Design RFP and Vendor Selection Frameworks with standardized evaluation tools and scoring documentation that produce consistent, defensible vendor decisions.
- Establish Contract and QTA Templates with standard-form contracts and Quality Technical Agreements aligned to GxP requirements and your supplier relationships.
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Vendor Oversight
Build a vendor oversight framework, risk assessment process, audit program, and performance governance structure into a single supplier management model.
No fragmented vendor management, no undefined accountability, no oversight gaps.
No fragmented vendor management, no undefined accountability, no oversight gaps.
- Design Your Vendor Oversight Framework with risk-based vendor categorization, governance structures, and oversight schedules calibrated to your supplier base and program stage.
- Develop Quality Agreements with agreement drafting and negotiation support for CROs, CDMOs, and other suppliers — agreements that define accountability clearly from the start.
- Build Audit Programs and Performance Scorecards with risk-based audit schedules, KPI frameworks, and reporting structures that provide real visibility into vendor performance between reviews.
- Structure CRO and CDMO Governance with oversight models built around the specific operational and quality dynamics of clinical and manufacturing partnerships.
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Spend
Build clinical budget models, financial governance processes, invoice controls, and spend reporting into a single connected financial management framework.
No disconnected budgets, no uncontrolled costs, no financial blind spots.
No disconnected budgets, no uncontrolled costs, no financial blind spots.
- Design Your Clinical Budget Framework with spend tracking structures, budget templates, and forecasting processes built around how your programs actually run — not a generic model.
- Establish Invoice and Milestone Controls with reconciliation processes that connect financial data to vendor performance, milestone delivery, and program objectives.
- Build Financial Governance SOPs with approval workflows, variance handling procedures, and documentation standards that keep spending decisions traceable and audit-ready.
- Connect Spend to Quality and Vendor Performance by designing financial oversight that surfaces the relationship between budget, vendor behavior, and quality outcomes — because a budget problem is often a vendor problem in disguise.
The Consulting Partner Your Program Deserves
Purpose-Built For Life Sciences Teams
Works With Your Existing Technology
Flexible Consulting For Every Program Stage
Built To Hold Up Under Scrutiny
Designed To Grow Into 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
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