Consulting & Build Studio

Process Engineering + Digital Twin Consulting

Partner with us to modernize CMC operations. We blend deep process engineering expertise with product-grade software delivery to build resilient, compliant, and automation-ready platforms.

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Digital Twin Architecture

Blueprint and implement the data + compute backbone for process models, equipment telemetry, and material genealogy.

Unified process data
System-of-record alignment
Scalable compute pipeline

CMC Analytics & Forecasting

Monte Carlo supply forecasts, batch performance analytics, and demand risk dashboards tailored to program stage.

Risk quantification
Inventory optimization
Executive-ready reporting

External Operations Enablement

CDMO oversight operating model: governance cadence, site dashboards, decision logs, and inspection-ready documentation patterns.

CDMO performance dashboards
Risk & issue management
GxP document control alignment

Automation & AI

RAG copilots, document automation, and CoA extraction to compress cycle times and free engineering bandwidth.

Reduced manual effort
Audit-ready automation
AI governance built-in

GxP Compliance Enablement

Part 11 audit trails, e-signature workflows, and validation documentation aligned to your CSV strategy.

Regulatory readiness
Immutable auditability
Traceability matrices

Engagement models

Flexible delivery options tailored to your program stage and technical maturity.

Advisory Sprint

2-4 weeks

Define the digital twin roadmap, prioritize tooling, and align stakeholders.

  • • Architecture blueprint
  • • Capability gap assessment
  • • Execution roadmap

Build & Launch

6-12 weeks

Ship production-ready modules with synthetic demo data and compliance scaffolding.

  • • Live tool prototypes
  • • Data model & APIs
  • • Validation artifacts

Transform & Scale

Ongoing

Embed automation, analytics, and AI across CMC operations with governance.

  • • Operational dashboards
  • • Automation pipelines
  • • Continuous improvement KPI

Why BioProcess Nexus?

A blend of biotech execution, regulatory fluency, and software product thinking.

Process-first design

We start from critical process parameters, not generic software templates.

Compliance embedded

Audit trails, signatures, and validation artifacts are part of day-one design.

Automation outcomes

We deliver measurable reductions in cycle time, manual effort, and risk exposure.

Ready to modernize your CMC stack?

Let us design, prototype, and deploy the systems that turn CMC data into decisions.

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