Life Sciences Consulting
Pharma. Biotech. CDMO. Regulated complexity is the norm.
We help you modernize without compromising compliance.
The Real Problem?
You don’t have a tech problem. You have a traceability problem.
- ERP, MES, LIMS, QMS—none of them talk.
- Finance can’t see batch-level cost.
- Ops can’t trust inventory.
- Quality’s buried in email chains.
- Auditors? Already circling.
What We Deliver
- Audit-Ready ERP: SAP S/4HANA, NetSuite, Oracle — Multi-site, multi-entity, with GxP controls baked in.
- MES Integration: PAS-X, Syncade — Real-time traceability, deviation control, and e-signatures.
- LIMS & QMS Automation: LabWare, Veeva, MasterControl — CAPAs, change control, and QC data flows.
- Cost & Inventory Intelligence: Batch-level COGS, serialized inventory, no more manual reconciliations.
- Pre-IPO & Commercial Scale: SOX controls, close acceleration, FP&A tool integration (Anaplan, Adaptive).
Who We Serve
- Biotech Companies: Typically newer, large-molecule innovators navigating early clinical phases. We help you scale your systems as you move from IND to IPO—without overengineering.
- Pharma Companies: Established small-molecule organizations, often multi-entity and globally distributed. We modernize legacy ERP, MES, and LIMS environments with traceable, compliant workflows.
- CMOs & CDMOs: Whether you're executing pure manufacturing (CMO) or developing and scaling formulations (CDMO), we build ERP + QMS workflows that support multi-client operations, batch-level cost visibility, and audit-proof controls.
Why LSC Systems
- GxP Built In: Traceability, documentation, and Part 11 compliance from day one.
- System Expertise That Matters: We know how PAS-X breaks and how Veeva gets misconfigured.
- Execution Over Theory: No decks. Just delivered systems that hold up under audit.
- We Speak FDA, Not Just APIs: IQ/OQ/PQ, audit trails, and validated access controls—standard in every build.
Still relying on manual workarounds?
The FDA won’t wait. Neither should you.
Book a Discovery Call View GxP Integration Playbook