New product development in pharma is governed by stage gates — checkpoints a project must pass before it advances. In theory they control risk and spend. In practice, many gates check a status colour in a review meeting rather than the evidence the gate was supposed to require, and projects advance on optimism.
The failure mode: gates that check status, not evidence
A gate that passes because someone set it to green is not a gate; it is a formality. The whole purpose of a stage gate is to ensure that specific evidence exists before capacity and money are committed to the next phase. When the gate checks a status instead of the artefacts, the control is hollow, and the organisation discovers missing evidence at the worst possible moment — usually during filing or inspection.
What each gate should actually require
Consider a typical path for an oral solid dosage product. At initiation, the gate should require a patent landscape assessment, established OEL and ADE, a documented PDE, a completed RMP form, and a raised SAP WBS so spend has somewhere to sit from day one. At product development, it should require formulation development evidence, method validation, and a stability protocol. At scale-up and exhibit batch, it should require batch manufacturing records, bioequivalence study reports, and the quality overall summary. At filing, the country dossier assembled and the submission tracked.
The principle is consistent: a gate opens when its evidence exists, not when a meeting agrees it should.
The PAF register: one view of every project's real state
A Product Approval Form register sits across all the gates and shows every project's stage, owner and ageing in one place. Its value is that it makes a stalled project visible without anyone having to ask. Instead of the loud projects getting attention and the quiet ones drifting, every project has a current, honest status — including the ones nobody has chased.
Why handovers between functions are where time is lost
Much of the delay in NPD is not in the work but in the gaps between functions — R&D, regulatory, IP and marketing each holding a version, each finding out late. When the PAF and its gates live in one place, with owners and dates attached to the evidence at the point it is decided, the handover delay between functions collapses from weeks to same-day. The evidence is where the decision is made, not emailed after it.
Gates as an asset, not an obstacle
Teams often experience stage gates as bureaucracy. Done well, they are the opposite: they are what lets you commit capacity and spend with confidence, because you know the evidence is real. A gate that genuinely requires its evidence protects the organisation from expensive late surprises — and a PAF register that shows the true state of every project protects it from quiet drift.