Preparing Your ERP For Life Sciences Commercialization

By Jim Ingram

Clinical-stage teams spend years working toward FDA approval, but many give far less thought to how they’ll run a commercial business once approval arrives. Companies that wait until approval to close the gap between their current systems and what commercialization demands often end up scrambling with compressed timelines, manual workarounds, and added compliance risk.

Why should operational readiness start well before launch? This article explains why and walks through four decisions that shape readiness: when to move to a commercial-ready ERP (enterprise resource planning) system, which manufacturing model to support, how much system validation is needed based on risk, and whether your partners can keep pace with your timeline. It also outlines what a launch-ready system should include, from inventory quarantine and release controls to electronic signatures and automated cost tracking. Find where your operations fall short today so your business is as ready for market as your therapy.