DeviSolve Pilot Program Now Open

AI Solutions for
Regulated Biopharma Supply Chains

AXUM AI Partners LLC leads AI strategy, solution design, and implementation oversight for regulated supply chain environments. DeviSolve, our AI-assisted deviation investigation platform for biopharma QA teams, is now open for pilot implementations with qualified companies.

GMP
Regulatory Expertise
AI
Strategy & Design
Fed
Advisory Support
24/7
Response Commitment

Where AI Strategy Meets
Regulated Supply Chain Execution

We help biotech, pharma, and public-sector-facing organizations define AI opportunities, architect practical solutions, and oversee delivery in environments where compliance, traceability, and execution discipline matter.

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AI Strategy, Architecture & Program Leadership

We lead AI initiatives from concept through implementation planning by defining solution architecture, agent workflows, business rules, and compliance-aligned operating models. As the prime contractor, we coordinate specialized development partners while maintaining responsibility for strategy, scope, and execution oversight.

AI StrategySolution ArchitectureAgent DesignProgram Oversight
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Regulated Biotech Supply Chain

We advise biopharmaceutical and biotech organizations on resilient supply chain design for regulated operations, including cold chain integrity, GMP-aligned processes, supplier oversight, and serialization readiness. Our focus is on building systems that support compliance and operational continuity from the start.

GMP ComplianceCold ChainDSCSA / SerializationSupplier Oversight
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Federal Advisory Support

We support organizations operating in federal and public-sector-adjacent environments that require disciplined supply chain planning, documentation, and procurement alignment. We help clients navigate traceability requirements, compliance expectations, and operational readiness under FAR and DFARS-informed frameworks.

Public Sector AdvisoryFAR / DFARSTraceability

Built for Regulated Operators, QA Leaders, and Supply Chain Teams

AXUM AI Partners supports organizations where AI adoption must align with compliance, documentation, traceability, and operational accountability.

Biotech and Biopharma Companies

We help regulated life sciences teams apply AI to supply chain, quality, and operational workflows while preserving human review, documentation discipline, and compliance accountability.

CDMOs and Regulated Manufacturers

We support organizations managing deviations, SOPs, supplier oversight, production constraints, and quality-system documentation across complex manufacturing environments.

Public-Sector-Facing Organizations

We advise organizations that need supply chain resilience, procurement alignment, traceability, and documentation readiness for government-adjacent or federally influenced operating environments.

Prime Contractor Leadership.
Compliance-First Execution.

We do not treat AI as an isolated technology layer. We structure AI-enabled supply chain solutions for regulated use, lead the program at the strategic level, and coordinate execution through specialized partners where needed.

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    Deep Biotech Domain KnowledgeStrong grounding in GMP, biologics, and regulated supply chain operations informs every engagement and keeps recommendations anchored in real-world constraints.
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    Prime Contractor AccountabilityWe lead the engagement, define the solution, coordinate technical delivery partners, and remain accountable for alignment, execution oversight, and client outcomes.
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    Federal Procurement FluencyExperienced in supply chain and compliance considerations relevant to federal acquisition environments and public-sector operational requirements.
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    Implementation-Ready DeliverablesOur recommendations, frameworks, and operating models are designed to support execution, documentation, and review in regulated and institutionally governed environments.

Credentials & Capabilities

  • βœ“Prime Contractor Model β€” Strategy, Oversight & Delivery Coordination
  • βœ“GMP / 21 CFR Part 211 Regulatory Framework
  • βœ“SAP SCM & ERP-Adjacent Process Knowledge
  • βœ“DSCSA Serialization & Track-and-Trace Readiness
  • βœ“AI Solution Design for Supply Chain Use Cases
  • βœ“Partner-Led Execution through Specialized Engineering Teams
  • βœ“Based in Silver Spring, MD β€” Serving clients nationwide

Introducing DeviSolve:
An AI Deputy for Biopharma QA Teams

DeviSolve is AXUM AI Partners' agentic deviation solver for FDA-regulated biopharma QA teams. It helps QA reviewers draft deviation investigations, CAPA plans, and form extractions in minutes while keeping every AI output advisory until a qualified reviewer approves it.

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Draft Deviation Investigations Faster

DeviSolve assists reviewers by drafting structured investigation content, including event summaries, immediate corrections, investigation narratives, root-cause rationale, product-impact assessment, and CAPA decision support. The reviewer remains in control of final content, edits, and approval.

Deviation DraftingRoot CauseProduct Impact
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Use SOPs and Prior Deviations as Context

The platform is designed to search approved SOPs, forms, and similar historical deviations so QA teams can work from relevant compliance context instead of manually searching PDFs, templates, and past investigations.

SOP ContextHistorical DeviationsCompliance Support
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Support CAPA Planning and Review

DeviSolve helps draft corrective and preventive action plans, identify potential SOP or training impacts, and propose realistic action items. Outputs are designed to support QA review, not replace human judgment or quality-system accountability.

CAPA DraftingTraining ImpactReviewer Approval

Pilot companies wanted

We are actively looking for biopharma, biotech, CDMO, and regulated manufacturing teams to evaluate DeviSolve in a pilot phase. The pilot is designed to onboard your SOPs and templates, run selected deviations through the AI-assisted workflow, and measure cycle-time reduction, reviewer acceptance, and practical fit with your current quality process.

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Let's Discuss Your
Supply Chain Priorities

Whether you're a biotech firm strengthening compliance readiness, a public-sector-facing organization improving supply chain resilience, or a company interested in piloting DeviSolve, AXUM AI Partners is ready to engage.

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Silver Spring, Maryland  |  Serving clients nationwide

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