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ERP and PMO consulting for life sciences operators.

Validated environments, traceability, and audit-readiness are non-negotiable — but they shouldn't paralyze a system change. We help life sciences leaders move forward without compromising compliance.

Where life sciences firms get stuck

  • ERP, QMS, and LIMS that don't share a clean source of truth for batch, lot, and serial data.
  • Validation effort that balloons because scope was never defined up front.
  • CAPA, deviation, and change-control workflows duct-taped across tools.
  • Partners who know the software but not the regulated operating model.

How we help

  • Vendor-neutral selection across ERP, QMS, MES, and LIMS with validation effort scoped from day one.
  • Process improvement on quality, traceability, and release workflows before automation.
  • Project delivery oversight that keeps GxP, IT, and operations rowing in the same direction.
  • PMO build-out to govern multi-site, multi-system programs under audit.

Evaluating systems in a regulated environment?

Whether you're picking ERP, replacing a QMS, or standing up a PMO for a validated rollout — let's talk before you sign anything.