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What you can engage Analysis Zero to deliver today.

Analysis Zero is a real-time quality control platform for biomanufacturing — built on a deployable PAT skid backed by an FDA Type II Drug Master File (DMFDrug Master File — a regulatory submission to the FDA that documents the analytical methods and equipment so sponsors can reference it directly in their filings.). Our services bring that capability directly to your facility, your molecules, and your regulatory dossier.

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Real-Time Release Testing

Deploy our PATProcess Analytical Technology — in-line sensors and software that measure product quality during manufacturing, replacing post-production lab tests. skid to your facility for in-line CQACritical Quality Attribute — a physical, chemical, or biological property that must be within defined limits for the product to be safe and effective. monitoring, validated against your offline reference methods. Backed by FDA Type II DMF.

  • ✓ Skid deployment and commissioning
  • ✓ In-line model validation against your reference methods
  • ✓ SOPs and regulatory documentation referencing our DMF
  • ✓ Real-time data dashboard and batch release reports

Typical engagement: 3–6 months  |  Pricing provided after consultation

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Chemometric Method Development

We build calibrated quantitative models for your specific analytes and matrices using our reference library and physics-aware synthetic-augmentation toolkit. Industry baseline is 3–9 months — we compress that to days or weeks.

  • ✓ Reference library access and customer-matrix calibration
  • ✓ PLS / transfer-learning spectral model development
  • ✓ Validated model with validation report
  • ✓ Model handoff in deployment-ready format

Typical engagement: days–weeks (known analytes)  |  Pricing provided after consultation

Ready to Engage?

Tell us about your molecule, your facility, and your timeline. We'll come back with a scoped proposal.

Schedule a Consultation